Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter B - HEARING AID SALES AND REGISTRATION
Section 25.215 - Denial, revocation or suspension of registrant's certificate

Universal Citation: 28 PA Code ยง 25.215

Current through Register Vol. 54, No. 44, November 2, 2024

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.

This section cited in 28 Pa. Code § 25.210 (relating to receipt to purchaser-purchaser protection).

Disclaimer: These regulations may not be the most recent version. Pennsylvania may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.