PERTH, AUSTRALIA — Wireless earbud maker, Nuheara, has reportedly petitioned the FDA to expedite the implementation of the Over The Counter (OTC) Hearing Aid Act legislation, which was signed into law by President Trump last fall.
The OTC legislation will allow for hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” for over the counter sale in the US. The bill also requests the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).
As part of the legislation, the FDA was given three years to complete the development of rules and regulations surrounding OTC devices. Manufacturers and hearing loss advocacy groups, however, are hopeful the process will be completed more quickly.
Nuheara Eyes OTC Hearing Aid Market
Nuheara, which recently announced product expansions and a unique partnership with the National Acoustics Laboratories and HEARing CRC, looks to move into the OTC category once the FDA completes the rule-making process. The company’s soon-to-be-launched IQbuds Boost earbuds are reportedly the only product on the market at this time that adheres to the OTC Act requirements.
Nuheara has asked FDA commissioner Scott Gottleib to accelerate the OTC Hearing Aid Act process and encouraged the FDA to consider a set of standards already prepared by the US Consumer Technology Association for OTC hearing aid regulation
In response to the request, William Maisel, from the FDA’s Center for Devices and Radiological Health said, “We are committed to implementing the legislation through a deliberative, transparent process, informed by notice and comment rule making as required by law. We share Nuheara’s enthusiasm for the tremendous potential of the legislation to increase access and quality of life for hearing impaired Americans.”
Nuheara’s CEO, Justin Miller, said his company agrees with the FDA’s objective to provide greater access and affordability of hearing healthcare and that his company is “already providing significant hearing accessibility benefits to consumers”.
Source: Manufacturer’s Monthly, Nuheara
