FDA Draft Guidance Document on PSAPs and Hearing Aids
The US Food and Drug Administration (FDA) has announced the reopening of its comment period regarding the agency’s 2013 Draft Guidance document on personal sound amplification products (PSAPs) and hearing aids.
According to the Hearing Industries Association (HIA), the Draft Guidance, when finalized, is intended to further clarify the regulatory distinctions between hearing aids and PSAPs. The FDA regulates hearing aids as medical devices, and originally provided guidance on hearing aids and PSAPs in 2009. In the 2009 Draft Guidance, the FDA stated that PSAPs are not subject to regulation since they are designed to enhance normal hearing rather than to address hearing loss. After issuing its original Draft Guidance, which bans the marketing of PSAPs as hearing aids, the FDA recognized that greater clarity was needed due to claims by some PSAP manufacturers relating to hearing loss.
In reopening the comment period, the FDA also requested comment on the availability, accessibility, and use of hearing aids and PSAPs for consumers with hearing loss. As previously reported in several articles about PCAST in The Hearing Review, the FDA requested comments on recommendations in the Letter Report issued by the President’s Council of Advisors on Science and Technology (PCAST) in October, including the recommendation to create a “basic” category of hearing aids for over-the-counter (OTC) sale. In that request, the FDA specifically solicited comments on whether the benefits of expanded OTC access outweigh the risks of foregoing the requirement for an evaluation to rule out treatable, potentially progressive causes of hearing loss.
The FDA also has announced that it will be holding a workshop on April 21, 2016 at its headquarters in Maryland on “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids” to discuss the appropriate level of GMP regulations. The FDA workshop will reportedly outline the agency’s perspective on the current GMPs that are required under the agency’s Quality Systems Regulation (QSR) and gather stakeholder and public input about alternative models for regulation that would accelerate innovation while still enabling quality design and manufacturing for hearing aids.
Source: FDA; HIA
President's Winter Message 2015
December 9, 2015
As the holidays and end of the year approach, I want to thank our CAA Board and all of our members for the support of your professional organization this year. It has been a busy year, and your Board members and management group have been working diligently on your behalf. After six long months without a management group, CAA hired JMS Association Management Professionals in June. They were up and running in a flash and have contributed immensely. We are so excited to have found such a professional and dedicated group!
Gareth Elliott Joins Sacramento Advocates
Barry Brokaw, senior partner of Sacramento Advocates, the lobbying firm that has represented CAA for the last 20 years, has announced that Mr. Gareth Elliott will be joining their firm as a partner. Mr. Elliott served as one of Governor Brown’s senior advisors, as well as his legislative affairs secretary since 2011. Governor Brown recently appointed Mr. Elliott to the University of California Board of Regents as well. Mr. Brokaw feels that this well-respected and experienced professional will be a great asset to Sacramento Advocates. More...(Posted 1/27/2015)
Right: Sacramento Advocates lobbying partner and Legislative Liaison Dr. Marcia Raggio at the Governor's reception "Celebrating Women Leaders in California" (held at the California State Railroad Museum, 4/21/15)
Save the Date for the 2016 CAA Conference
Save the date for the 17th Annual CAA Conference which will be held at the DoubleTree by Hilton in San Diego Mission Valley
September 8–10, 2016
More information will be sent out in the upcoming months.
SB 1326 AMENDMENTS TO THE SONG-BEVERLY CONSUMER WARRANTY ACT
The Song-Beverly Consumer Warranty Act (SBCWA) now provides a 45-day warranty on all new and used hearing aids. Dispensers of hearing aids may provide a longer period than 45 days. If extending the warranty period beyond 45 days, the change must be specified in the required SBCWA language. The SBCWA warranty is the defined period that the consumer has the right to return the hearing aid. The term "warranty" in SBCWA does not refer to the hearing aid manufacturer's warranty. The dispenser must provide the buyer with a opy of the signed purchase agreement that includes the above SBCWA language verbatim. Upon delivery of the hearing aid, the dispenser shall provide the buyer with a delivery receipt that must include the delivery date and expiration date of the 45-day warranty period.
For all adjustments, replacements, or services that require the hearing aid to be out of the buyer's possession, the warranty period will be tolled and will resume on either the date the repaired or serviced hearing aid is redelivered to the buyer, or five days after the buyer is notified that the hearing aid is available for the buyer's possession.
Click here for an example of the Requirements for Purchase Agreement.
Click here to view the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board's document pertaining to the amended Song-Beverly Consumer Warranty Act
Ask your Senators to Support the Hearing Aid Tax Credit Act (S. 315)
The Hearing Aid Tax Credit Act (S. 315) has been introduced by Senators Dean Heller (R-NV) and Amy Klobuchar (D-MN). This legislation will provide a tax credit of up to $500 towards the purchase of a hearing aid, available once every five years with no restrictions based on age or income. This has the potential to improve patient access to hearing aid technology. For more information and to access a sample letter to send to your legislator visit this web page.
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