In August 2017, Congress passed the FDA Reauthorization Act of 2017 (FDARA) which included the OTC Hearing Act of 2017. The Act mandates the Food and Drug Administration (FDA) to establish a category of over‐the‐counter (OTC) hearing aids.
These new devices will use “the same fundamental scientific technology” as (wireless) air conduction hearing aids and will be available over‐the-counter without the supervision of a licensed hearing care professional.
The legislation requires FDA to promulgate regulations for this category that provide “reasonable assurances of safety and effectiveness,” “adopt output limits appropriate for over the counter hearing aids,” “requirements under which the sale of over the counter hearing aids is permitted,” and are appropriately labeled.
The FDA is considerIng a rule that treats this new category of OTC hearing aids as consumer electronic devices. This is a major concern for patients, caregivers and hearing health professionals. The leading medical and industry authorities on hearing care have concluded that OTC hearing aids must be treated and regulated as medical devices NOT consumer electronics.
FDA must ensure that these devices are safe and effective by the industry’s recommendation set forth in the Consensus Paper:
- Limit the maximum output level, or the maximum amount of sound level that the device can produce up to 110 dB
- Limit the gain level, or the amount of power (amplification) that the device can add to any incoming sound it processes, to 25 dB.
- Require appropriate internal/external labeling that clearly states that OTC hearing aids are medical devices intended for use only by adults (minimum age 18) with specified level of loss, and include a notice that hearing loss is a medical condition best addressed in consultation with a hearing care professional; information of any medically treatable causes of hearing loss.