The FDA regulates the sales of hearing aids and implantable devices. In their recent “Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,” issued on: February 25, 2009, the FDA provided the regulatory definition of hearing aids. Read the FDA’s regulation [View PDF]
U.S. Food and Drug Administration Workshop to be Streamed with Captions; Communication Access Realtime Translation On-Site
January 29, 2016
A public workshop being convened by the U.S. Food and Drug Administration (FDA) in April 2016 will be streamed with captions, and Communication Access Realtime Translation (CART) will be provided on-site.
The workshop is in response to a report by the President’s Council of Advisors on Science and Technology (PCAST) , whose recommendations included that the FDA exempt hearing aids from the Quality System Regulations (QSRs). The workshop is to discuss the current QSRs and Good Manufacturing Practices (GMPs) for hearing aids and to consider an alternative model for quality verification
The workshop is open to the public, but requires registration by April 13, 2016. Written comments can be submitted until May 19, 2016.
FDA Seeks Input on Over-the-Counter (OTC) Hearing Aids
January 12, 2016
The U.S. Food and Drug Administration (FDA) issued two notices related to hearing aids, referencing the President's Council of Advisors on Science and Technology (PCAST) report to the President: Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. (A PCAST report summary can be found here and the full report can be found here.) The FDA is also mindful of the ongoing efforts of the Committee on Accessible and Affordable Hearing Health Care for Adults at the Institute of Medicine (IOM).
The two notices are in reference to:
1. Reopening the comment period on the Personal Sound Amplification Products (PSAPs) Draft Guidance
When the FDA issued the Draft Guidance on PSAPs, it allowed a period of public comment, to which HLAA submitted comments. In light of the PCAST and IOM activities, the FDA is reopening the public comment period. The deadline for comments is May 4, 2016.
The FDA asks parties to comment on three issues raised by PCAST:
- The degree to which current FDA requirements are a barrier to hearing aid accessibility, affordability and use;
- The appropriateness of creating a category of “basic” hearing aids with labeling for OTC sale;
- Whether or not the benefits of OTC hearing aids would outweigh the risks of foregoing the requirement of medical evaluation.
2. An FDA Public Workshop on Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids – April 21, 2016
Reacting to the PCAST recommendation that the FDA exempt hearing aids from the Quality System Regulations (QSRs), a public workshop is being convened by the FDA to discuss the current QSRs and GMPs for hearing aids and to consider an alternative model for quality verification. The FDA will also consider the possible use of alternative quality standards developed by standards development organizations and key stakeholders. The workshop is open to the public, but requires registration by April 13, 2016. Written comments can be submitted until May 19, 2016.
HLAA will be submitting comments and plans to participate in the Public Workshop on April 21, 2016.
HLAA Comments on PSAPs and Hearing Aids
February 5, 2014: HLAA filed comments with the Food and Drug Administration (FDA) regarding their draft guidance entitled:
"Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.''
This draft guidance is intended to clarify the distinction between hearing aids and personal sound amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is not final nor is it in effect at this time.
In our comments, HLAA raises concerns with the draft guidance, and urged the FDA to seek input from a broad range of stakeholders to work together to craft a document that is helpful to industry, providers and consumers alike as well as provide for greater education of consumers.
Food and Drug Administration (FDA) Clears the Way for Hearing Aid Manufacturers to Label Hearing Aids with Immunity Information
Brenda Battat associate executive director of SHHH and Carol Rogin executive director of the Hearing Industries Association (HIA) met July 26, 2005 with FDA officials to discuss hearing aid labeling for compatibility with mobile phones.
SHHH believes that hearing aid labeling based on the ANSI C63.19 standard is necessary to help consumers select a hearing aid and mobile phone that should work together without interference. The FCC requires that mobile phones be rated and labeled according to the same ANSI standard.
Hearing aid manufacturers have been unwilling to label their hearing aids with the immunity level to interference when used with mobile phones. They are concerned that if a hearing aid does not measure up to the label that the company could face regulatory action by the FDA. The FDA has assured HIA that if a hearing aid is labeled according to a standardized laboratory test in accordance with ANSI C63.19 that the FDA would not take enforcement action against a product that conveyed that information on the label. Nor would the FDA “have concerns about an assertion on the label of a hearing aid that individual hearing users will have varying results with cell phones.”1
SHHH’s position is that the hearing aid industry should label its products to inform consumers of the immunity level of the hearing aid they are purchasing. The labeling should provide adequate information to help consumers buy a mobile phone. The information should be consistent with the C63.19 standard. We are fully aware that testing in the laboratory in the prescribed way may not mirror 100% what happens in real-life usage and that hearing aids customized after purchase may perform differently. Therefore, consumers should try the hearing aid with the mobile phone in the store before purchasing and take advantage of the trial period and refund/exchange policy to test the phone and hearing aid together in real life situations
We understand that the FDA cannot approve labeling language but support and encourage the FDA’s offer to give assurance in writing to the hearing aid manufacturers that the labeling language does not violate health regulations.
SHHH also requests that the hearing aid manufacturers give testing data to hearing aid dispensers explaining in plain language the immunity levels of the products they sell so that they in turn can inform consumers of the immunity level of the hearing aid they are purchasing.
Associate Executive Director
1FDA WT Docket No. 01-309 Ex Parte letter to FCC July 2nd, 2003
Manufacturers’ Group Asks FDA to Crack Down on Crypto-Hearing Aids
By David H. Kirkwood, Hearing Health Matters 4/2/2012
The Hearing Industries Association (HIA) has called on the Food and Drug Administration (FDA) to start enforcing its regulations governing hearing aids, even when the devices are ostensibly “personal sound amplification devices” or PSAPs.
In an April 19 letter to Steven Silverman, director of the Office of Compliance at FDA’s Center for Devices and Radiological Health, Jeffrey Gibbs, HIA’s counsel, cited a number of products that are being sold online without FDA’s clearance even though, he said, they are clearly intended to be used as hearing aids, and not as PSAPs, which are not approved for use by people with hearing loss.
Gibbs told the FDA official, “We request that you take enforcement action against the companies making hearing aid claims for their PSAPs.” He added, “Given the widespread nature of these violations, and the abuse of the [FDA] guidance document ‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,’ we request that you revise the PSAP Guidance to both tighten and reinforce the limits of the claims that may be made by PSAP manufacturers.”
For the full article, see http://tinyurl.com/8xyun8x
Thanks to Bob MacPherson and Cheryl Heppner