Over the Counter Hearing Aids

The Over the Counter Hearing Act of 2017 requires the FDA to create a category for certain hearing aids intended for use by adults over the age of 18 years with mild to moderate hearing loss. The device will be available over the counter without the supervision, prescription, or other order, involvement or intervention of a licensed person to customers through in-person transactions, by mail or online.

Currently, hearing aids are intended to compensate for impaired hearing and are programmed to fit a specific hearing loss by hearing professionals who are licensed in the state where they practice. The hearing evaluation determines the maximum power output of the hearing aid and the gain and frequency response that will be required to restore audibility and maintain comfort.

The new category will allow the consumer through “tools, tests, or software…to control the over-the-counter hearing aid and customize it to the user’s hearing needs.” OTC devices may include tests for self-assessment of hearing loss. These applications are currently available on a variety of hearing aids that can be used by the consumer or adjusted remotely by a hearing professional.

The Over the Counter Hearing Aid Act of 2017 states that the new category will use the same fundamental technology as traditional hearing aids.  The labeling requirements will differ from existing hearing aids considering that the new category will be sold without the involvement of a professional.

OTC products can be distinguished from Personal Sound Amplification Devices (PSAPs) which are wearable electronic products that are not intended to compensate for impaired hearing but rather intended for non-hearing-impaired consumers to amplify sounds in certain environments, such as hunting or other recreational activities.

The FDA missed the statutory August 18 deadline to propose a rule to create a category for OTC hearing aids. Initially expected by the end of 2020, we continue to monitor for eventual release of the proposed rule. This will be followed by a comment period of probably 60 days.  FDA will then have six months to review the comments, make any changes in the proposal, write a preamble, and obtain all necessary signoffs.

Hearing Health Care Professional Associations Consensus Paper

In August of 2018, the major representatives of the hearing healthcare professionals, the American Academy of Audiology (AAA), Academy of Doctors of Audiology (ADA), American Speech-Language and Hearing Association (ASHA) and International Hearing Society (IHS), released a Consensus Paper with five key recommendations for the new rule. The recommendations are:

1. Product requirements for OTC devices with a) the 2 cc coupler HFA full on gain, as measured at an input level of 50 dB SPL per ANSI S3.22-2014, is 25 dB or lower; and b) the peak (or maximum) 2 cc coupler OSPL90, per ANSI S3.22-2014, is not greater than 110 dB SPL in combination with input compression and volume control.
2. Outside-the-box labeling should include recognition of intended use/usage and an important notice for  the  prospective  users  about  hearing  loss  being  a  medical  condition  best  addressed  in  consultation  with  a  licensed professional.
3. Inside-the-box labeling should include a strong warning that the device is not intended for children under the age of 18. Additionally, inside-the-box should include a User Instructional Manual with direction to the consumer on how to identify lack of benefit and what to do.
4. FDA  to name  the new category as “Self-Fit Over-the-Counter Hearing Devices” and to maintain for such category the same risk classification as air conduction hearing aids – i.e. Class I for non-wireless devices and Class II (exempt) for  wireless  OTC  hearing  devices.  Additionally,  the  Working  Group  strongly recommends that any 510(k) exemptions be limited to devices that have received a first time  FDA  marketing  authorization  (a  510(k)  clearance).  The  initial  OTC  air conduction hearing devices should be required to undergo the 510(k) processes.
5. FDA to establish strong consumer protection laws (e.g. return and refund policies, unsubstantiated and false claims…) and the necessary processes and resources to enforce then.

HIA endorsed the Consensus Paper recommendations and has encouraged the FDA to include them in the proposed rule.

How Could OTC Regulations Impact State Laws?

• Maintaining Consumer Protections for All Hearing Aids: five areas of concern for the FDA's pending OTC hearing aid regulation - October 2020

Request for Status

• Joseph P. Kennedy III and Earl L. "Buddy" Carter to FDA Commissioner Stephen Hahn, MD - October 27, 2020
• Elizabeth Warren and Chuck Grassley to FDA Commissioner Stephen Han, MD – November 13, 2020
• Mike Thompson and David McKinley to FDA Commissioner Stephen Hahn, MD – December 16, 2020