(a)  Scope. This subchapter applies to all persons engaged in the business of selling or fitting hearing aids in this Commonwealth; except that physicians and audiologists are exempted from all provisions regarding hearing aid fitters.

 (b)  Authority. This subchapter is adopted under the act.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

   Act—The Hearing Aid Sales Registration Law (35 P. S. § §  6700-101—6700-802).

   Advertise and any of its variants—The use of a newspaper, magazine or other publication, book, notice, circular, pamphlet, letter, handbill, poster, sign, placard, label, tag, window display, store sign, radio, television announcement, Internet, or other means or methods employed to bring to the attention of the public the practice of selling or fitting hearing aids.

   Audiologist—A person who holds a current license as an audiologist issued by the State Board of Examiners in Speech-Language and Hearing, or a person who is permitted to practice audiology pursuant to an exemption to the audiologist licensure requirement under section 6(b) of the Speech-Language and Hearing Licensure Act (63 P. S. §  1706(b)).

   Authorized representative—A person who is authorized by law to make a decision, required pursuant to this subchapter, for a hearing aid user or prospective hearing aid user.

   Business of selling hearing aids—

     (i)   Selling, leasing or offering for sale or lease new, used or reconditioned hearing aids exclusive of parts, attachments or accessories, at retail, either as exact replacements for damaged or worn out units or written specifications provided by an audiologist, otologist or otolaryngologist.

     (ii)   The term does not include fitting or the practice of fitting and selling hearing aids.

   Continuing education program—A program approved by the Department for credit towards the continuing education requirements for the renewal of the registration certificate of a hearing aid fitter.

   Conviction—A plea or verdict of guilty, or a conviction following a plea of nolo contendere to a charge of a crime involving moral turpitude.

   Department—The Department of Health of the Commonwealth.

   Fitting—Includes the physical acts of adjusting the hearing aid to the individual, taking audiograms, making ear molds, advising the individual with respect to hearing aids, making audiogram interpretations and assisting in the selection of a suitable hearing aid to sell a hearing aid.

   Hearing aid—A wearable instrument or device designed or offered to aid or compensate for impaired human hearing together with any parts, attachments or accessories for those instruments or devices, including ear molds but excluding batteries and cords.

   Hearing aid dealer—A person engaged in the business of selling hearing aids.

   Hearing aid fitter—An individual engaged in the practice of fitting and selling hearing aids.

   Hearing aid user—An individual who uses a hearing aid.

   Practice of fitting and selling hearing aids—Those practices used solely for making selections, adaptations and sales of hearing aids.

   Prospective hearing aid user—An individual who is considering buying a hearing aid or whose hearing is being evaluated by a registrant.

   Purchaser—An individual who has agreed to purchase a hearing aid from a registrant.

   Registrant—A hearing aid dealer or fitter holding a current certificate of registration.

   Secretary—The Secretary of Health of the Commonwealth.

   Sponsor—An individual registered in this Commonwealth as a hearing aid fitter who agrees to supervise an apprentice hearing aid fitter.

   Used hearing aid—

     (i)   A hearing aid that has been worn for any period of time by a user.

 (a)  The Advisory Council (Council) will be composed as provided for under section 201 of the act (35 P. S. §  6700-201).

 (b)  It will be the duty of the Council to advise the Secretary, to the best of its ability, on the administration of the act.

 (c)  The Council will hold at least one annual meeting at a time and place designated by the Secretary for the purpose of providing information and advice to the Department.

 (a)  Application. An application for registration or renewal of registration as a hearing aid dealer, hearing aid fitter, apprentice hearing aid fitter or temporary hearing aid fitter can be obtained from the Division of Home Health, Pennsylvania Department of Health, 132 Kline Plaza, Suite A, Harrisburg, Pennsylvania 17104.

 (b)  Apprentice hearing aid fitter. A completed application for registration as an apprentice hearing aid fitter shall be filed with the Department at least 30 days before the fitter’s examination that the applicant intends to take, together with a check, money order or other approved method of payment as the Department publishes in a notice in the Pennsylvania Bulletin, in the amount of $50. An additional $150 shall be paid before taking the fitter’s examination. The application fee is not refundable, but the $150 fee for the examination will be refunded to an applicant who is found to be ineligible to take the examination.

 (c)  All other registrations. A completed application for any registration certificate, other than a registration certificate as an apprentice hearing aid fitter, may be filed at any time, together with a check, money order or other approved method of payment as the Department publishes in a notice in the Pennsylvania Bulletin, in the amount of the appropriate application fee.

 (d)  Renewal of current certificate. A registrant shall apply to renew a current registration certificate by March 16 prior to the certificate’s expiration, by submitting a completed renewal application, available from the Department, along with the renewal fee of $100. To renew a hearing aid fitter’s registration certificate, the applicant shall also demonstrate satisfaction of the continuing education requirements under §  25.216 (relating to continuing education requirements).

 (e)  Renewal of expired certificate. An expired registration certificate may be renewed within 5 years after its expiration or inactive date by filing an application for renewal, with payment of the renewal fee, and payment of the delinquency fee if the application is received more than 30 days after the expiration date. To renew an expired hearing aid fitter’s registration certificate, the applicant shall also demonstrate satisfaction of the continuing education requirements under §  25.216.

 (f)  Renewal of fitter’s temporary registration certificate and apprentice certificate. Upon application, the Secretary may renew a temporary certificate or apprentice certificate for a period which shall expire 30 days after the next available fitter’s qualifying examination has been given. The Secretary will not issue more than two renewals of these certificates, except upon petition of an applicant for good and sufficient cause shown. An applicant may petition the Department for an additional renewal. The petition shall include the reasons for which the additional renewal is requested. An applicant shall send a petition for additional renewal to the Division at the address given in subsection (a). The Department will then decide whether to issue the renewal.

 (g)  Late application for renewal. A person who files for renewal of a registration certificate after March 16 may not receive the renewal before the registration certificate expires.

 (a)  Hearing aid dealers. No requirement is imposed in addition to those imposed under §  25.204(c) (relating to application for and renewal of registration).

 (b)  Hearing aid fitters. A hearing aid fitter shall pass the qualifying examination as provided by the act.

 (c)  Reciprocal registration—certificate by endorsement.

   (1)  An applicant for registration to practice as a hearing aid dealer or as a hearing aid fitter who is licensed or registered in any other state, which has requirements equal to or greater than those in this Commonwealth for registration as a hearing aid dealer or fitter and which maintains reciprocal practice privileges with this Commonwealth, may be granted a registration certificate by endorsement by the Secretary. Being qualified to apply for a hearing aid fitter’s registration certificate by endorsement relieves the applicant from having to take the qualifying examination otherwise required under the act.

   (2)  In all other respects, the applicant for a registration certificate by endorsement shall be registered in the same manner and meet the same requirements as other registrants.

   (3)  If the Commonwealth does not maintain reciprocal practice privileges with a state in which a person is registered or otherwise authorized to function as a hearing aid fitter or dealer, the person may apply for a temporary registration certificate under subsection (e).

 (d)  Apprentice registration. Apprentice registration shall conform to the following:

   (1)  An applicant for registration as an apprentice hearing aid fitter shall have a sponsor responsible for the training and supervision of the applicant.

   (2)  An application shall be accompanied by a statement of the sponsor:

     (i)   Setting forth the type of supervision which shall be given the applicant.

     (ii)   Providing an outline of the training program to be followed in preparing the applicant for examination. The training program shall include education and training in at least the following areas:

       (A)   The anatomy and physiology of the ear.

       (B)   The function of hearing aids.

       (C)   The grounds for revocation or suspension of a certificate of registration, or probation of a registrant, under the act.

       (D)   The violations and penalties under the act.

       (E)   The procedures and use of equipment established by the Department for the fitting and selling of hearing aids.

       (F)   The taking of ear mold impressions.

       (G)   The medical and rehabilitation facilities for children and adults that are available in the areas served.

       (H)   The criteria for medical referral when found to exist either from observation by the registrant or on the basis of information furnished by the prospective hearing aid user, to include those criteria in §  25.211(d) (relating to medical recommendations; waiver forms).

     (iii)   Providing the registration number of the sponsor.

   (3)  An apprentice hearing aid fitter desiring to change sponsors shall furnish the Department a sworn or affirmed request giving reasons for the change and a sworn or affirmed statement from the new sponsor setting forth the information required by paragraph (2), and accompanied by the apprentice’s certificate of registration. An affirmed statement may be given in any form so long as it is in writing, signed, and contains a statement to the effect that it is truthful.

   (4)  A sponsor desiring to terminate responsibilities with regard to an apprentice shall give the apprentice 10 days written notice of the reasons for the action and shall notify the Department at the same time by certified mail.

 (e)  Temporary registration. Temporary registration shall conform to the following:

   (1)  A temporary fitter’s registration certificate will be issued to an applicant who satisfactorily demonstrates having been engaged in the fitting and selling of hearing aids at an established place of business in a state other than this Commonwealth for 2 years within a 5-year period immediately before making application and who otherwise fulfills the requirements of the act and this subchapter.

   (2)  The temporary registrant shall take the hearing aid fitter’s examination to qualify for a regular hearing aid fitter’s registration certificate.

   (3)  The temporary registration certificate shall expire 30 days after the administration of the qualifying examination that the temporary registrant takes. The temporary registrant shall take the qualifying examination no earlier than 90 days after the date the temporary registration certificate was issued, and no later than 1 year after the date the temporary registration certificate was issued.

 (a)  An examination to obtain registration as a hearing aid fitter shall be held at least twice each year, at a time and place to be fixed by the Secretary at least 45 days before the examination date.

 (b)  The date of an examination may be obtained by writing to the Division at the address given in §  25.204(a) (relating to application for and renewal of registration), by checking the Department’s website at www.health.state.pa.us, or by phone or e-mail to the Division.

 (a)  A registration certificate, other than a temporary or apprentice registration certificate, shall expire at midnight of April 15 of each year, if not renewed.

 (b)  For a hearing aid dealer, the initial registration fee is $200 if the Department issues the registration certificate between April 15 and October 14, and $100 if the Department issues the registration certificate between October 15 and April 14. The annual renewal fee is $100 for both dealers and fitters.

 (c)  For a hearing aid fitter’s registration certificate, the initial registration fee is $200, $150 of which will be refunded if the applicant is ineligible to take the qualifying fitter’s examination. The annual renewal fee is $100.

 (d)  For a registration certificate by endorsement the fees shall be the same as in subsection (b).

 (e)  For a temporary hearing aid fitter’s registration certificate, the initial registration fee is $200, $150 of which is for the examination. A refund of the $150 will be made if the applicant is ineligible to take the qualifying examination for a fitter’s registration certificate. Instead of paying the full $200 when making the application, the applicant may pay $50 when making the initial application, and $150 before taking the examination for the first time. The renewal fee is $100.

 (f)  For an apprentice fitter’s registration certificate, the fee is $50 plus an additional $150 before the apprentice takes the fitter’s examination. The renewal fee is $100.

 (g)  For a duplicate or replacement registration certificate, the fee is $10. The registrant shall obtain a duplicate certificate upon the loss of an original certificate or for a branch office. The registrant shall obtain a replacement registration certificate upon a name change by the person holding a certificate.

 (h)  The fee to retake the fitter’s examination for an applicant who has previously failed the examination is $50.

 (i)  A delinquency fee will be assessed if an applicant applies for renewal of a registration certificate after May 15. The delinquency fee is $50.

 (a)  A registrant shall display the dealer’s or fitter’s registration certificate at the place of business listed in the registrant’s application.

 (b)  If a registrant maintains more than one place of business within this Commonwealth, the registrant shall apply for a duplicate registration certificate for each branch office. The registrant shall display the appropriate duplicate registration certificate in each office.

 (c)  The place of business identified in a registrant’s application shall be an office at a fixed location. An office which is part of a building normally used as a residence shall be in a space set aside for office purposes only.

 (d)  A registrant shall file notice of a change in the registrant’s place of business with the Department at least 10 work days before the change by writing to the Department at the address given in §  25.204(a) (relating to application for and renewal of registration).

 (a)  Facilities. A registrant shall engage in the practice of fitting or selling a hearing aid only if the registrant provides:

   (1)  An appropriate test area, the ambient noise level of which shall have a documented readout of 55 dB or lower on the A scale of a sound level meter.

   (2)  A selection of hearing aid models, supplies and accessories to provide for the immediate needs of hearing aid users or prospective hearing aid users.

 (b)  Procedures. A registrant shall satisfy the following:

   (1)  The registrant shall sell a hearing aid only if within 6 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. This requirement does not apply when the registrant is replacing a hearing aid with another of the same make, model and response. The registrant shall sell a hearing aid replacing another of the same make, model and response only if within 12 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. The registrant shall verify that the tests were performed by an individual authorized by law to do so. The registrant may rely on a representation by the physician, audiologist or fitter who performed or supervised the tests that the individual who performed the tests was authorized to do so.

   (2)  The registrant shall:

     (i)   Perform air conduction tests for hearing level thresholds at frequencies of 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz and 6,000 Hz or 8,000 Hz, with masking if necessary.

     (ii)   Perform bone conduction tests for hearing level thresholds at frequencies of 500 Hz, 1,000 Hz, 2,000 Hz and 4,000 Hz, with masking if necessary.

     (iii)   Maintain records of the test results for each ear for 7 years.

     (iv)   Perform a speech reception or speech awareness threshold test using an electronic speech audiometer with head or insert ear phones.

     (v)   Perform a word discrimination or other speech intelligibility test for conversational level speech using an electronic speech audiometer with head or insert ear phones.

   (3)  The registrant shall sell a hearing aid only if the hearing aid is fitted to the wearer to ensure physical and operational comfort and improvement in hearing function is demonstrated and documented in at least one of the following areas: speech detection, speech awareness levels, speech intelligibility, orientation or speech reception threshhold.

 (c)  Instrumentation. A registrant shall satisfy the following:

   (1)  All test instruments shall be calibrated once each year or more often if necessary to meet current American National Standards Institute standards for pure tone and speech audiometry as identified by 1996 A.N.S.I. standards or applicable succeeding A.N.S.I. standards.

   (2)  Instruments transported to test sites shall be calibrated to the standard set forth in paragraph (1) every 6 months, or more frequently as needed.

   (3)  Calibration shall be performed by a qualified individual other than the owner.

   (4)  A signed certificate identifying the most recent date of calibration shall be maintained for inspection by the Department.

 (a)  Receipt. Upon the sale of a hearing aid, the registrant shall provide the purchaser a signed receipt. The receipt may be made out on more than one sheet of paper and shall contain the following:

   (1)  The date of sale.

   (2)  The make, model and serial number or, if no serial number is applicable, an identification number of the hearing aid.

   (3)  The address of the principal place of business of the registrant.

   (4)  If the hearing aid is used or reconditioned, a statement which provides that information and which meets the requirements of §  25.215(23) (relating to denial, revocation or suspension of registrant’s certificate).

   (5)  The registrant’s registration certificate number.

   (6)  The terms of any guarantee or express warranty made to the purchaser with respect to the hearing aid.

   (7)  A copy of the written forms as required by §  25.211 (relating to medical recommendations; waiver forms).

   (8)  A statement on or attached to the receipt, in no smaller than 10 point type, as follows:

 ‘‘The purchaser has been advised at the outset of his relationship with the hearing aid dealer that any examination or representation made by a registered hearing aid dealer and fitter in connection with the practice of fitting and selling of this hearing aid, is not an examination, diagnosis or prescription by a person licensed to practice medicine in this Commonwealth and therefore must not be regarded as medical opinion.’’

   (9)  A statement on the face of the receipt, in no smaller than 10 point bold type, as follows: ‘‘If your rights are violated, you may contact the State Bureau of Consumer Protection, the Pennsylvania Department of Health in Harrisburg, or your local district attorney.’’

 (b)  Disclosure agreement and money back written guarantee. Before the provision of any service incidental to or connected with the potential sale of a hearing aid, the registrant shall provide a disclosure agreement and money back written guarantee to the prospective hearing aid user or authorized representative, and shall explain it in detail in accordance with subsection (c). This shall be in 10 point type or larger, and may be made out on more than one sheet of paper, but shall employ the following format or be on a form approved by the Department:

HEARING AID DISCLOSURE AGREEMENT/MONEY BACK GUARANTEE

 (Business Name)

 Telephone No. (  )

 PART A.

 THIS DISCLOSURE AGREEMENT WAS PROVIDED, PARTS A AND B WERE EXPLAINED, AND PART A (FEES FOR SERVICES NOT PART OF THE PRICE OF THE HEARING AID) WAS COMPLETED AT

 NOTHING IN THIS DISCLOSURE AGREEMENT SHALL RELIEVE A REGISTRANT OF THE OBLIGATION TO REFUND ALL OR PART OF THE ABOVE FEES, INCLUDING THOSE LISTED AS NOT REFUNDABLE, IF A COURT DETERMINES THAT THE REGISTRANT HAS VIOLATED A PENNSYLVANIA CONSUMER PROTECTION LAW IN THE SALE OR FITTING OF THE HEARING AID (OR SIMILAR DEVICE) AND IF THE COURT ORDERS SUCH REFUND.

 PART B.

   30 Day Money Back Guarantee: If a hearing aid is returned within 30 days of date of delivery in the same condition, ordinary wear and tear excluded, you are entitled to a refund of the portion of the purchase price of the hearing aid and accessories as itemized on the receipt and above, less the cancellation fee stated above. If a cancellation fee is imposed the nonrefundable amount for each aid and accessories cannot exceed 10% of the purchase price of the hearing aid and accessories or $150.00 per aid and accessories, whichever is less. You will, however, be responsible for all nonrefundable service fees listed in Part A. If you cancel your order prior to delivery, you are entitled to full refund of the purchase price of the aid and accessories, and a full refund for services not yet rendered.

 (c)  Additional responsibilities of registrant with respect to the disclosure agreement/money back guarantee.

   (1)  Before providing any services incidental to the possible sale of a hearing aid to the prospective hearing aid user, the registrant shall explain Part A of the disclosure agreement/money back guarantee to the prospective hearing aid user or authorized representative and shall complete Part A. The registrant shall also give a preliminary explanation of Part B, including any cancellation fees that may be retained if a purchaser decides to return a hearing aid. The registrant shall include in Part A a complete description of what the fitting procedure or process includes, and shall itemize and disclose fees associated with the fitting procedure or process and the sale and delivery of the hearing aid. For each service provided, the registrant shall identify by dollar amount the portion of the fee that is refundable and the portion that is not refundable. If a fee will be waived if a hearing aid is purchased, that shall be stated. If the registrant charges no fees for services, the registrant shall note that in Part A.

   (2)  After Parts A and B have been explained and Part A has been completed, the registrant shall have the prospective hearing aid user or authorized representative complete the time and date lines provided under Part A. The prospective hearing aid user or authorized representative and registrant shall also sign under Part A when appropriate.

   (3)  After completing the necessary testing, if it is determined that a hearing aid will be recommended, the registrant shall explain and complete Part B, itemizing any cancellation fee associated with the sale and delivery of a hearing aid and its accessories by designating that amount as ‘‘not refundable.’’ Part B shall be fully explained and completed before any payment is made. If Part B becomes inapplicable due to a decision by the registrant, prospective hearing aid user or authorized representative not to proceed further after testing, the disclosure agreement/money back guarantee need not be fully completed. The registrant shall provide a copy of the partially completed disclosure agreement/money back guarantee to the prospective hearing aid user or authorized representative.

   (4)  If the registrant and the prospective hearing aid user or authorized representative decide to proceed, the registrant shall explain the 30-day money back guarantee. If the prospective user or authorized representative decides to purchase a hearing aid, the registrant shall have the purchaser sign the second signature line on the disclosure agreement/money back guarantee and complete the line for date and time of sale, and shall also sign when appropriate.

   (5)  The registrant may revise the relevant portion of the disclosure agreement/money back guarantee form to disclose the registrant’s policy of offering a money back guarantee return period longer than 30 days. The money back guarantee shall be for at least 30 days from the date of delivery.

   (6)  After the disclosure agreement/money back guarantee is fully completed except for the date of delivery block and the hearing aid serial numbers, the registrant shall provide a copy of it to the hearing aid user or authorized representative.

   (7)  At the time the hearing aid is delivered to the hearing aid user or authorized representative, the registrant shall ensure that the signature or initials of the user or authorized representative is obtained and the date of delivery and serial number are inserted in the block or section provided for that purpose on the disclosure agreement/money back guarantee. After the block is completed with the initials or signature and date and the serial number is inserted, the registrant shall provide a copy of the completed disclosure agreement/money back guarantee to the purchaser.

 (a)  Except when selling a replacement of a worn out or damaged hearing aid, when selling a hearing aid for the use of a prospective hearing aid user who is 19 years of age or older, a registrant shall either obtain for the prospective user a medical recommendation that complies with §  25.212 (relating to medical recommendations by examining physicians), or ensure that the prospective user or authorized representative signs a waiver form as provided under section 403 of the act (35 P. S. §  6700-403). The waiver form shall be prepared and used as follows:

   (1)  The waiver form shall be in 10 point type or larger.

   (2)  The waiver shall be read to the prospective hearing aid user or authorized representative and explained in a manners that the individual is not encouraged to waive a medical examination and so that the individual will be thoroughly aware that signing the waiver will not be in the prospective hearing aid user’s best interest.

   (3)  The waiver form shall read as follows:

 I have been advised that my best interests would be served if I had a medical examination by an otologist or otolaryngologist or any licensed physician before my purchase of a hearing aid.

 (b)  When selling a replacement of a worn out or damaged hearing aid for the use of a prospective hearing aid user who is 18 years of age or older, a registrant shall either obtain for the prospective user a medical recommendation that complies with the requirements of §  25.212, or ensure that the prospective user or authorized representative signs a legally proper waiver of the medical examination. For purposes of this subsection, a legally proper waiver includes a medical waiver form as provided under section 403 of the act and described in subsection (a), or a Federal medical waiver form as approved by the Food and Drug Administration of the United States Department of Health and Human Services.

 (c)  Except when a registrant is selling a hearing aid to replace an identical hearing aid, the registrant may sell a hearing aid for the use of a prospective user 18 years of age or younger only if the registrant obtains a medical recommendation that complies with the requirements of §  25.212 and is signed by a physician specializing in otolaryngology or otology. When selling an identical replacement hearing aid for the use of an individual under 18 years of age, the registrant shall obtain a medical recommendation that complies with the requirements of §  25.212.

 (d)  Before the sale of a hearing aid a registrant shall inform the prospective hearing aid user or authorized representative, in writing, that it would be in the best interest of the prospective hearing aid user to consult a physician specializing in or qualified to deal with diseases of the ear if the prospective hearing aid user has any of the following conditions:

   (1)  Visible congenital or traumatic deformity of the ear.

   (2)  Active drainage from the ear within the previous 90 days or a history of this symptom.

   (3)  Sudden or rapidly progressive hearing loss within the previous 90 days or a history of this symptom.

   (4)  Acute or chronic dizziness.

   (5)  Unilateral hearing loss of sudden or recent onset within the previous 90 days.

   (6)  Visible evidence of cerumen accumulation or a foreign body in the ear canal.

   (7)  Significant air-borne gap of 15dB or greater at 500 Hz, 1000 Hz and 2000 Hz.

   (8)  Pain in the ear within the previous 90 days.

 (a)  Whenever a medical examination is performed under the act or Federal requirements, before fitting and selling a hearing aid the registrant shall ensure that a medical recommendation has been signed by the examining physician, within 180 days before the sale, on a form which includes the following statement or its equivalent:

 I have medically evaluated the hearing ability of

 and a hearing aid may be beneficial to this person.

 (b)  If the prospective hearing aid user is 18 years of age or younger, the registrant shall ensure that the prospective user’s date of birth has been included on the medical recommendation form.

 (a)  Before signing a waiver form under §  25.211 (relating to medical recommendations; waiver forms) and before the sale of a hearing aid to or for the use of a prospective hearing aid user, the registrant shall:

   (1)  Provide the prospective hearing aid user or authorized representative with a copy of the User Instructional Brochure for the hearing aid that has been or may be selected for the prospective user.

   (2)  Review the content of the User Instructional Brochure with the prospective hearing aid user or authorized representative orally or in the predominant method of communication used during the sale.

   (3)  Give the prospective hearing aid user or authorized representative an opportunity to read the User Instructional Brochure.

 A registrant shall, upon the consummation of a sale of a hearing aid, keep and maintain records in the registrant’s office or place of business at all times. These records shall be kept for 7 years and shall include the following:

   (1)  Results of all testing conducted under §  25.209 (relating to facilities, procedures and instrumentation). The minimum acceptable test records shall be records of:

     (i)   Pure tone tests including air and bone conduction with masking where appropriate, and the ambient noise level of the test area.

     (ii)   Speech reception threshold expressed in decibels of hearing level.

     (iii)   Most comfortable level expressed in decibels.

     (iv)   Uncomfortable (tolerance) level expressed in decibels.

     (v)   Word discrimination test results expressed in percentage indicating the test words used, presentation level, masking level (if applicable), and signal to noise ratio (if applicable).

   (2)  A copy of the written receipt, disclosure agreement and money back guarantee required by §  25.210 (relating to receipt, disclosure agreement and money back guarantee to purchaser—purchaser protection).

 The Secretary may deny, suspend or revoke a registration certificate provided under the act or the Secretary may impose conditions of probation upon a registrant for any of the following causes:

   (1)  Gross incompetency which includes the improper or unnecessary fitting of a hearing aid.

   (2)  Conviction of a felony or misdemeanor involving moral turpitude.

   (3)  Obtaining a registration certificate by fraud or deceit.

   (4)  Using the term ‘‘doctor’’ or ‘‘physician’’ or ‘‘clinic’’ or ‘‘audiologist’’ or any derivation thereof as part of the firm name under which the registrant fits and sells hearing aids, unless authorized by law.

   (5)  Fraud or misrepresentation in the repair, fitting or selling of a hearing aid.

   (6)  Employing a person to perform a function within the scope of practice of a hearing aid fitter who is not authorized by law to perform the function.

   (7)  Habitual intemperance.

   (8)  Gross immorality.

   (9)  Permitting another person to use the registration certificate for any purpose, except permitting an audiologist or physician employed by the registrant to sell hearing aids for the registrant.

   (10)  Violating or, with notice or knowledge permitting an employee to violate, the act or this subchapter.

   (11)  A cause which would be a ground for denial of an application for a registration certificate.

   (12)  Having been enjoined from violating a provision of the Unfair Trade Practices and Consumer Protection Law (73 P. S. § §  201-1—209-6) or being subject to a final order of the Federal Trade Commission, the Department, or the Food and Drug Administration of the United States Department of Health and Human Services, concerning the sale or offering for sale of an unsafe, unhealthful or worthless hearing device or for engaging in conduct which has the tendency to mislead or deceive.

   (13)  Using, causing or promoting the use of any advertising matter, promotional literature, testimonial, guarantee, warranty, label, brand, insignia or any other representation, however disseminated or published, that is misleading, deceiving, improbable or untruthful, such as a misrepresentation relating to:

     (i)   The grade, quality, quantity, origin, novelty, price, dealer cost, terms of sale, use, construction, size, composition, dimensions, type, design, development, visibility, durability, performance, fit, appearance, efficacy, benefits, cost of operation, resistance to climatic conditions, or physiological benefits of a hearing aid or the psychological well-being induced by a hearing aid.

     (ii)   A service or adjustment offered, promised, or supplied to a purchaser of a hearing aid, or the fee associated with the service or adjustment.

   (14)  Making a representation that a hearing aid is ‘‘guaranteed,’’ without clear and conspicuous disclosure of:

     (i)   The nature and extent of the guarantee.

     (ii)   A material condition or limitation of the guarantee which is imposed by the guarantor.

     (iii)   The manner in which the guarantor will perform thereunder.

     (iv)   The identity of the guarantor, with disclosure, if applicable, that any guarantee made by the registrant which is not backed up by the manufacturer is offered by the registrant only.

     (v)   The meaning of ‘‘life’’ or ‘‘lifetime’’ to clarify whether it refers to the life of the purchaser, the product, or otherwise, whenever representations are made that a hearing aid is ‘‘guaranteed for life’’ or has a ‘‘lifetime guarantee.’’

   (15)  Making a guarantee, warranty, or promise which, under normal conditions, is impractical of fulfillment or which is for a period of time or of a nature that may cause a purchaser to believe that the hearing aid has a greater degree of service ability, durability or performance capability in actual use than is true.

   (16)  Making a misrepresentation as to the character of the business conducted by the registrant. Unless it is true, a registrant may not represent directly or indirectly through the use of any word or term, in the corporate or trade name, in advertising, or otherwise, that the registrant owns or maintains a laboratory devoted to hearing aid research, testing, experimentation or development. A registrant may not misrepresent in any other material respect the character, extent or type of business conducted by the registrant.

   (17)  Causing deception that services or advice of a physician were used in the design or manufacture of hearing aids. Unless it is true, a registrant may not represent, directly or by implication, that the services or advice of a physician have been used in the designing or manufacturing of hearing aids. The prohibitions of this paragraph are applicable to the use of the terms ‘‘doctor,’’ ‘‘physician,’’ ‘‘otologist’’ or ‘‘otolaryngologist,’’ to the use of any abbreviations, variations or derivatives of those terms; and to the use of any symbol, depiction, or representation having a medical connotation.

   (18)  Making a deceptive representation as to the visibility or the construction of a hearing aid. A registrant may not do any of the following:

     (i)   Represent, directly or by implication, through the use of such words or expressions as ‘‘invisible,’’ ‘‘hidden,’’ ‘‘hidden hearing,’’ ‘‘completely out of sight,’’ ‘‘conceal your deafness,’’ ‘‘hear in secret,’’ ‘‘unnoticed even by your closest friends,’’ ‘‘no one will know you are hard of hearing,’’ ‘‘your hearing loss is your secret,’’ ‘‘no one need know you are wearing a hearing-aid,’’ ‘‘hidden out of sight when inserted in the ear canal’’ or by any other words or expressions of similar import, that any hearing aid, device, or part is hidden or cannot be seen unless it is hidden or cannot be seen.

     (ii)   Represent directly or by implication that a hearing aid utilizing bone conduction has a specified feature such as the absence of anything in the ear or leading to the ear, or the like, without disclosing clearly and conspicuously that the instrument operates on the bone-conduction principle and that, in many cases of hearing loss, this type of instrument may not be suitable.

   (19)  Making an advertisement or other representation which may have the tendency or effect of misleading or deceiving a purchaser or prospective purchaser to believe that a hearing aid or device or part or accessory thereof is a new invention or involves a new mechanical or scientific principle, when that is not true. Representations of the following or similar types, when not fully justified by the facts, are among those prohibited by this paragraph: ‘‘amazing new discovery,’’ ‘‘revolutionary new invention,’’ ‘‘radically new and different,’’ ‘‘sensational new laboratory development,’’ ‘‘remarkable new electronic device,’’ ‘‘brand new invention,’’ ‘‘marvelous new hearing invention,’’ ‘‘new scientific aid’’ and ‘‘miracle.’’

   (20)  Misrepresenting the commercial nature of the registrant’s business. A registrant may not represent, directly or by implication, that a commercial hearing aid establishment is a governmental or public one or is a nonprofit medical, educational or research institution, through the use of a term having a medical, professional or scientific connotation, such as ‘‘Hearing Center,’’ ‘‘Hearing Institute,’’ ‘‘Hearing Bureau,’’ ‘‘Hearing Clinic,’’ ‘‘State’s Hearing Clinic,’’ or ‘‘State’s Speech and Hearing Center.’’ Nothing in this paragraph precludes a registrant from representing, if true, that the registrant owns, operates or controls a ‘‘Hearing Aid Center’’ or from using other words or expressions which clearly and nondeceptively identify the registrant’s establishment as a commercial hearing aid enterprise.

   (21)  Making a deceptive advertisement of a hearing aid part, accessory or component. A registrant may not use or cause to be used any type of advertising or promotional literature depicting or describing only a single part, accessory or component of a hearing aid or device, such as a battery on the finger or a transistor held in the hand, in a manner that may have the tendency to mislead or deceive a purchaser or prospective purchaser to believe that the part, accessory or component is all that must be worn or carried.

   (22)  Making a deceptive testimonial or other endorsement. A registrant may not advertise or otherwise represent that:

     (i)   A particular individual, organization or institution endorses, uses or recommends the registrant’s hearing aids or devices when that is not true.

     (ii)   A particular individual wears the registrant’s hearing aids or devices when that is not true.

   (23)  Making a representation either directly or indirectly that a hearing aid or part thereof is new, unused or rebuilt when that is not true.

     (i)   In the marketing of a used hearing aid or a hearing aid which contains used parts, a registrant shall make full and nondeceptive disclosure of the fact in advertising and promotional literature relating to the product on the container, box or package in which the product is packed or enclosed. The required disclosure may be made by use of words such as ‘‘used,’’ ‘‘second-hand,’’ ‘‘repaired’’ or ‘‘rebuilt,’’ whichever applies to the product involved, and it shall appear on a tag physically attached to a hearing aid.

     (ii)   A registrant may not misrepresent the identity of the rebuilder of a hearing aid. If the rebuilding of a hearing aid was done by other than the original manufacturer, a registrant shall disclose the fact wherever the original manufacturer is identified.

   (24)  Doing any of the following:

     (i)   Representing or using a seal, emblem, shield or other insignia which represents, directly or by implication that a hearing aid or device has been tested, accepted or approved by an individual, concern, organization, group or association unless it is true and unless the hearing aid or device has been used in a manner as will reasonably ensure the quality and performance of the instrument in relation to its intended use and the fulfillment of a material claim made, implied or intended to be supported by the representation or insignia.

     (ii)   Representing that a hearing aid or device tested, accepted or approved by an individual, concern, organization, group or association has been subjected to a test based on a more severe standard of performance, workmanship and quality than is true.

     (iii)   Making any other false, misleading or deceptive representation respecting the testing, acceptance or approval of a hearing aid device by an individual, concern, organization, group or association. It is not necessary for an individual hearing aid or device to be tested if the method employed is a sample testing and full and nondeceptive disclosure of this fact is given in advertising and otherwise.

     (iv)   Making a false, misleading or deceptive representation regarding the practice of another registrant or the quality of a hearing aid product made by a hearing aid manufacturer, which enhances or is likely to enhance the registrant’s business as a repairer, fitter or seller of hearing aids.

   (25)  Doing any of the following:

     (i)   Imitating or simulating the trademark, trade name, brand or label of a competitor which may have the tendency or effect of misleading or deceiving a purchaser or prospective purchaser.

     (ii)   Using in advertising the name, model name or trademark of a particular manufacturer of hearing aids in a manner that implies a relationship with the manufacturer that does not exist or which otherwise may mislead or deceive a purchaser or prospective purchaser.

     (iii)   Using a trade name, corporate name, trademark or other designation which may have the tendency or effect of misleading or deceiving a purchaser or prospective purchaser as to the name, nature or origin of a hearing aid or of a material used therein or which is false, deceptive or misleading in another material respect.

   (26)  Advertising a particular model, type or kind of hearing aid for sale when a purchaser or prospective purchaser responding to the advertisement cannot purchase or is dissuaded from purchasing the advertised model, type or kind, if it is established that the purpose of the advertisement is to obtain prospects for the sale of a different model, type or kind than that advertised.

     (i)   In determining whether there has been a violation of this paragraph, consideration will be given to acts or practices indicating that the offer was not made in good faith for the purpose of selling the advertised product but was made for the purpose of contacting prospective purchasers and selling them a product or products other than that offered. Among acts or practices which will be considered in making that determination are the following:

       (A)   The creation, through the initial offer or advertisement, of a false impression of the product offered in a material respect.

       (B)   The refusal to show, demonstrate or sell the product offered in accordance with the terms of the offer.

       (C)   The disparagement, by acts or words, of the product offered or the disparagement of the guarantee; credit terms; or availability of service, repairs or parts or the disparagement in another respect, in connection with it.

       (D)   The showing, demonstrating and in the event of sale, delivery of a product which is unusable or impractical for the purpose represented or implied in the offer.

       (E)   The refusal, in the event of sale of the product offered, to deliver the product to the purchaser within a reasonable time thereafter.

       (F)   The failure to have available a quantity of the advertised product at the advertised price sufficient to meet reasonably anticipated demands.

     (ii)   It is not necessary that each act or practice set forth in subparagraph (i) be present to establish that a particular offer violates this paragraph; any one will be sufficient.

   (27)  Failing to furnish evidence of the required continuing education or truthful information regarding the continuing education secured when applying for renewal of a registration certificate as a hearing aid fitter.

 (a)  General requirements. Except as provided in subsection (d), the continuing education requirement for renewal of a hearing aid fitter’s registration certificate is 20 hours of continuing education credit in the 2 years immediately preceding the expiration of the current registration certificate. If the applicant for renewal has had a registration certificate for less than 2 years, the required number of continuing education hours shall be calculated by prorating the number of credit hours required over a 2-year period by the number of months in which the applicant for renewal had the registration certificate which is about to expire. Only months in which the applicant had the registration certificate for at least 15 days shall be considered in the calculations.

 (b)  Requirements for renewal of an expired registration certificate. Except as provided in subsection (d), the continuing education requirement for renewal of a hearing aid fitter’s registration certificate that has expired is 20 hours of continuing education credit in the 2 years immediately preceding the filing of the application for renewal, provided that the application for renewal is filed within 5 years after expiration of the previous registration certificate. If more than 5 years have passed since the registration certificate expired, the registration certificate may not be renewed. Instead, the individual shall repeat the hearing aid fitter’s certification examination and satisfy other requirements then in effect for an original hearing aid fitter’s registration certificate.

 (c)  Requirements for renewal of a suspended registration certificate. The continuing education requirement for renewal of a hearing aid fitter’s registration certificate which has been suspended is the same as in subsections (a) and (d). If the individual does not satisfy the continuing education requirement during the period in which the hearing aid fitter’s registration certificate is suspended, the suspended registration certificate shall be considered to have expired, and the continuing education requirements in subsection (b) shall apply for renewal of the expired registration certificate.

 (d)  Phase-in requirements. The first 2-year period for which continuing education requirements shall be required began on April 15, 2003.

 (e)  Subject matter requirements. Any subject matter that contributes directly to the professional competence, skills and education of a hearing aid fitter is acceptable subject matter for a continuing education program. At least one-half of all continuing education credit hours by which the hearing aid fitter seeks to qualify for renewal of the registration certificate shall be secured in some combination of the following core subject matter: hearing evaluation, hearing instrumentation technology, ear mold technology, hearing aid repair and maintenance, technical devices to assist the hearing-impaired, psychology of the hearing-impaired, and office procedures and compliance with the act.

   The provisions of this §  25.216 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B. 2808.

 (a)  A person may apply to the Department for approval of a continuing education program by submitting to the Department an application on a form supplied by the Department. The applicant shall supply the information requested in the application, including specification of whether the program is fully or partially devoted to any of the core subjects specified in §  25.216(e) (relating to continuing education requirements). The Department will grant approval of a continuing education program and designate whether the program is assigned full or partial credit in one of the core subjects, if the applicant satisfies the Department that the program the applicant will offer will meet the following minimum standards:

   (1)  The program shall contribute directly to the professional competence, skills and education of a hearing aid fitter.

   (2)  The program instructors shall possess the necessary practical and academic skills to conduct the program effectively.

   (3)  Program materials shall be clear, informative, grammatical, carefully prepared, readable and distributed to attendees at or before the time the program is offered whenever practical.

   (4)  The program shall be presented by a responsible instructor who is experienced and knowledgable in the subject matter being taught, in a setting that is conducive to learning the material being taught, including any necessary equipment and facilities, and is devoted to the educational purpose of the program.

   (5)  The program shall be open to persons who have a current, suspended or expired hearing aid fitter’s registration certificate.

 (b)  Approval of a continuing education program shall be effective for 3 years.

 (c)  If renewal of the Department’s approval of a continuing education program is desired, at least 90 days before expiration of the 3-year period the person who offered the program shall apply to the Department to renew the Department’s approval of that program. The criteria and process applicable to the Department’s initial approval of a continuing education program shall apply to renewal of the approval of that program.

 (a)  Credit hour. A hearing aid fitter shall receive 1 hour of credit for each 50 minutes of instruction in a continuing education program presented in a classroom setting. Credit may not be given if attendance or other participation in the program is not adequate to meet the educational objectives of the program as determined by the person offering the program. For completing a continuing education program that is not presented in a classroom setting, the hearing aid fitter shall receive the number of credit hours assigned to the program by the Department.

 (b)  Program completion. A hearing aid fitter shall receive no credit for a continuing education program not completed, as evidenced by satisfaction of the check-in/check-out process for a continuing education program presented in a classroom setting and the continuing education report verifying that the hearing aid fitter completed the program, both of which are submitted to the Department by the person who offered the program. The program shall also not be considered completed if the hearing aid fitter does not satisfy other program completion requirements imposed by this subchapter and the continuing education provider.

 (c)  Continuing education credit for instruction. A hearing aid fitter shall receive credit equal to the number of hours served as an instructor in a continuing education program approved by the Department, or in a program that satisfies requirements for initial certification as a hearing aid fitter, except that only half of the credit hours necessary for renewal of a hearing aid fitter’s registration certificate may be obtained through serving as an instructor. The remaining credits necessary to renew a certificate shall be obtained through attendance at continuing education programs.

 (d)  Repeat completion or teaching of a continuing education program. The Department will not accept more than one completion or teaching of a continuing education program for credit toward renewal of a fitter’s registration certificate, but will accept a subsequent completion or teaching of the same continuing education program for a subsequent renewal of a fitter’s registration certificate.

 (e)  Continuing education credit through endorsement. A hearing aid fitter who attends or teaches a continuing education program offered outside this Commonwealth may apply to the Department to receive credit for the program. The hearing aid fitter shall have the burden of demonstrating to the Department that the course meets standards substantially equivalent to the standards imposed in this subchapter. The Department will assign credit to the program, including the possibility of no credit or partial credit, based upon considerations of whether the program bears entirely upon appropriate subject matter and whether the method of presenting the program meets standards substantially equivalent to those prescribed in this subchapter.

 (f)  Continuing education credit assigned to self-study courses. Credit may be sought from the Department for a self-study continuing education program. The hearing aid fitter shall submit an application to the Department to approve the self-study program for credit before commencing the program and shall supply the Department with the materials the Department requests to conduct the evaluation, which may include any of the materials used in the course. The Department will assign credit to the program based upon considerations of whether the program addresses appropriate subject matter and whether the method of completing the program meets standards substantially equivalent to those prescribed in this subchapter. The Department may require modifications to the proposed self-study as a precondition to approving it for credit. If the materials are unavailable to the fitter prior to taking the course, the fitter may apply to the Department for credit after completing it. However, the Department reserves the right to disapprove the course for credit after it has been completed if it does not meet the standards prescribed in this subchapter.

 (g)  Continuing education credit assigned to courses not presented in a classroom setting. A hearing aid fitter shall be awarded credit for completing a continuing education program without the hearing aid fitter physically attending the program in a classroom setting, provided the program has been approved by the Department for credit when presented in that manner.

 (h)  Resolution of discrepancies. The Department will resolve all discrepancies between the number of continuing education credits reported and the number of continuing education credits a hearing aid fitter alleges to have earned. To help resolve disputes, the hearing aid fitter should retain the original certificate of completion of a continuing education program if a certificate of completion has been received by the hearing aid fitter.

 (a)  Record of attendance. A person who offers a continuing education program shall maintain a record of attendance for a program presented in a classroom setting by maintaining a check-in/check-out process approved by the Department, and shall assign at least one person to ensure that all individuals attending the course check in when entering and check out when leaving. If an individual enters a course after the starting time, or leaves a course before the finishing time, the assigned person shall ensure that the time of arrival or departure is recorded for the individual.

 (b)  Reporting attendance. A person who offers a continuing education program shall report to the Department, in the manner and format prescribed by the Department, attendance at each continuing education program presented in a classroom setting.

 (c)  Course evaluation. A person who offers a continuing education program shall develop and implement methods to evaluate the program to determine its effectiveness. The methods of evaluation shall include providing a program evaluation form to each person who attends the continuing education program, and requesting each person to complete the form.

 (d)  Record retention. A person who offers a continuing education program shall retain the completed program evaluation forms and the check-in/check-out record for a program presented in a classroom setting. The person shall retain the records for at least 4 years from the presentation of the program.

 (e)  Providing records. A person who offers a continuing education program shall promptly provide the Department with complete and accurate records relating to the program as requested by the Department.

 (f)  Program not presented in a classroom setting. A person who offers a continuing education program shall be exempt from the requirements of subsections (a) and (b) for a program which is not presented in a classroom setting, if the program is approved by the Department for credit when presented in that manner. When presenting the program to the Department for approval for credit, the person shall present a procedure for monitoring, confirming and reporting hearing aid fitter participation in a manner that achieves the purposes of subsections (a) and (b).

 (g)  Monitoring responsibilities. A person who offers a continuing education program shall ensure that the program was presented in a manner that met all of the educational objectives for the program, and shall determine whether each hearing aid fitter who enrolled in the program met the requirements of this subchapter and of the continuing education program to receive credit for completing the program.

 (h)  Program completion. A person who offers a continuing education program shall report to the Department, in a manner and format prescribed by the Department, completion of a continuing education program by a hearing aid fitter who completes the program, and shall identify to the Department a hearing aid fitter who seeks credit for a program but who did not meet the requirements of the program or this subchapter to receive continuing education credit. The person who offers a continuing education program shall also provide a hearing aid fitter who completes the program with a document certifying completion of the program.

 Upon request of a Department representative during regular and usual business hours, or at other times when that representative possesses a reasonable belief that a violation of this subchapter may exist, and upon the representative presenting documentation to identify himself as a representative of the Department, a registrant or person who offers a continuing education program shall:

   (1)  Produce for inspection equipment and supplies maintained pursuant to this subchapter.

   (2)  Produce for inspection, permit copying and provide within a reasonable period of time, records maintained under this subchapter.

 The Department may grant an exception to a requirement of this subchapter for good cause shown, except for a statutory requirement that is repeated in this subchapter.