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 25.211 - Medical recommendations; waiver forms

Universal Citation: 28 PA Code ยง 25.211

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

(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.

____________

(Registrant's Name) has fully and clearly informed me of the value of such medical examination. After such explanation, I voluntarily sign this waiver. I choose not to seek a medical examination before the purchase of the hearing aid.

_________________________

(Signature of Registrant)

_________________________

(Address of Registrant)

_________________________

(Signature of Purchaser)

_________________________

(Date of Signature)

(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.

This section cited in 28 Pa. Code § 25.205 (relating to additional application requirements); 28 Pa. Code § 25.210 (relating to receipt to purchaser-purchaser protection); 28 Pa. Code § 25.213 (relating to consumer review); and 28 Pa. Code § 25.214 (relating to recordkeeping).

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.