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. We learned that the FDA continues to work toward producing a rule by the end of 2020. 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.
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:
HIA endorsed the Consensus Paper recommendations and has encouraged the FDA to include them in the proposed rule.