Hearing Aid Regulations

Hearing Aid Sales Regulations

The amendments to existing regulations issued July 6, 2002 included continuing education requirements for hearing aid fitters, provide for 30-day money back written guarantees on hearing aids, and revise certification fees for consistency with the statute. Pursuant to Act 153 of 1998, amending the Hearing Aid Sales Registration Act, 35 P. S. §§ 6700-101--6700-802.

Public comment on the proposed amendments closed August 5, 2002. Independent Regulatory Review Commission comments on the proposed amendments were issued 9/5/02. Final-form regulation was subsequently issued by the Department of Health and may be viewed in the Pennsylvania Bulletin online at:
www.pabulletin.com/secure/data/vol34/34-22/942.html and
www.pabulletin.com/secure/data/vol34/34-22/942a.html.

Hearing Aid Dealers and Fitters
Hearing Aid Sales Regulation

Pennsylvania Hearing Aid Dealers and Fitters are regulated and licensed by the Department of Health, Bureau of Quality Assurance, Bureau of Facility Licensure and Certification, under direction of the Deputy Secretary for Quality Assurance.

Department of Health
Bureau of Quality Assurance
Health and Welfare Building - Room 930
Harrisburg, PA 17120
717-787-8015 v
1-877-PA-HEALTH

Registration required. These §§ 25.201-25.215 (relating to hearing aid sales and registration) are issued pursuant to Act 262 of 1976 (P.L.1182), The Hearing Aid Sales Registration Law. On December 21, 1998, Act 262 was amended by enactment of Act 153 of 1998 (HB558) which requires a 30-day money back written guarantee for hearing aid sales and imposes continuing education requirements for license renewal. It appears the Dept. of Health is continuing to formulate regulations implementing provisions of Act 153.

• §25.201 Application
• §25.201 Definitions
• §25.203 Advisory Council
• §25.204 Application and renewal
• §25.205 Special application requirements
• §25.206 Examinations.
• §25.207 Categories of registrations fee schedule
• §25.208 Display of registration certificates; offices
• §25.209 Facilities, procedures and instrumentation
• §25.210 Receipt to purchaser—purchaser protection
• §25.211 Waiver forms
• §25.212 Medical recommendations by examining physicians
• §25.213 Consumer review
• §25.214 Recordkeeping
• §25.215 Denial, revocation, or suspension of registrant’s certificate

Since the legislature obviously believes that the license already held by physicians and audiologists is adequate proof of their competence to fit patients with hearing aids, they are not required to take a qualifying examination prior to obtaining a hearing aid dealers certificate. Pennsylvania Hearing Aid Dealers Association, Inc. v. Department of Health, 417 A.2d 1340 (Pa. Cmwlth. 1980).

According to the Pennsylvania Attorney General's Consumer Booklet, Buying a Hearing Aid, The Hearing Aid Sales Registration Law provides consumers purchasing a hearing aid in Pennsylvania with various rights and protections.

• Every hearing aid dealer and fitter must be registered with the Pennsylvania Department of Health and the registration certificate must be conspicuously posted in their office or place of business.
• During the initial contact, hearing aid dealers and fitters must advise you that any examination or representation made by them regarding the hearing aid is not an examination, diagnosis or prescription by a person licensed to practice medicine and therefore must not be regarded as a medical opinion. You should receive this information in writing.
• During the six months prior to purchasing a hearing aid, you must have received an examination by an otologist, otolaryngologist or any licensed physician and a written recommendation stating that the use of a hearing aid may be beneficial. However, this rule does not apply to replacement parts, accessories or a worn out or damaged hearing aid. It also does not apply if you sign a written waiver. This waiver must be read and explained to you in a manner that does not encourage you to waive a medical examination and which thoroughly advises you of the consequences of signing it. You must be given a copy of this written waiver with your receipt.
• When certain medical conditions regarding your ears are found to exist, the dealer or fitter must suggest to you in writing that it is in your best interests to consult a licensed physician specializing in diseases of the ear. They then may not sell you and fit you for a hearing aid without a written recommendation from a licensed physician that a hearing aid may be beneficial to you.
• Before the dealer or fitter can provide any services to you, he or she must give you a disclosure agreement that must be explained to you in detail and be signed by you and the dealer or fitter. This disclosure agreement must contain a complete description of what the fitting procedure or process does and does not include, and must itemize and disclose any and all fees.
• Before the sale of any hearing aid to you, the dealer or fitter must give you a copy of the User Instructional Brochure for the hearing aid, review the content of the brochure with you, and give you an opportunity to read the brochure.
• At the time of the sale, the dealer or fitter must give you a written receipt signed by the dealer or fitter which contains important information regarding the hearing aid and the dealer or fitter. This receipt must also advise you that if your rights are violated, you may contact the Attorney General’s Bureau of Consumer Protection or the Pennsylvania Department of Health.
• The sale of each hearing aid must be accompanied by a 30-day money-back written guarantee. This guarantee must allow you to return the hearing aid within 30 days of the date of delivery in the same condition as when purchased, ordinary wear and tear excluded. You will be entitled to a refund of the purchase price of the hearing aid and accessories within 30 days of their return. However, a dealer may retain a cancellation fee which may not exceed the lesser of 10% of the purchase price or $150.

Consumer Protection Laws for PA

• Trial Period – 30 days
• Refund of full purchase price less 10% or $150, whichever is less, excluding nonrefundable services
• Complaints

  State Bureau of Consumer Protection
  www.attorneygeneral.gov/complaints.aspx?id=451
  Bureau of Consumer Protection, Administrative Office
  14th Floor, Strawberry Square
  Harrisburg, PA  17120
  717-787-9707

There is a section on Hearing Aids on the Hearing Loss Association of America website at www.hearingloss.org/learn/hearingaids.asp and a checklist for purchasing a hearing aid at
www.hearingloss.org/learn/docs/HLAAHearingAidChecklist_4-14-2009.pdf.

 

©2009 Hearing Loss Association of Pennsylvania. All rights reserved.

DISCLAIMER: Documents on this website have been compiled by the Hearing Loss Association of Pennsylvania as an information resource. The content is believed to be accurate at the time of posting, but much of the material is subject to frequent change. No warranty of accuracy or suitability for any particular use is made or implied. Please report any errors or omissions to the Webmaster at webmaster@hla-pa.org.