Regulatory Issues

Over-the-Counter (OTC) Hearing Aids

In August 2017, Congress passed the Over-The-Counter Hearing Aid Act of 2017 as an attachment to the FDA Reauthorization Act. The 2017 act mandates the Food and Drug Administration (FDA) to create a separate category of over-the-counter hearing aids available without the supervision or involvement of a licensed person.

As the Food and Drug Administration (FDA) begins to act on Congress’ mandate to create a new category of Over-The-Counter (OTC) hearing aids, four areas need to be properly addressed to ensure compliance with FDA’s mission towards safety and effectiveness while pursuing access and affordability.

HEARING ASSESSMENT:
Recommend a hearing assessment with a licensed hearing care professional

Issue:

Studies confirm the inability of individuals, in many cases, to self-determine degree and laterality of their hearing impairment as well as if any other relevant medical condition is present.

Solution:

Inform consumers that hearing loss is a medical conditions and suggest them to consult with a hearing professional even before the purchase of an OTC device.

PRODUCT SPECIFICATIONS:
Define requirements consistent with status of medical devices

Issue:

Congress’ mandate to the FDA to create a category of OTC hearing aids implies the intent that these devices will be regulated as medical devices. In reality, there is a risk that OTC hearing aids may follow standards of existing consumer electronic amplification products.

Solution:

FDA should set and mandate specific requirements appropriate for OTC hearing aids a) maximum output level, or the maximum amount of sound level that the device can produce, should be limited to 110 dB and b) gain level, or the amount of power (amplification) that the device can add to any incoming sound it processes, be limited to 23 dB.

INTENDED USERS:
Limit the access to individuals with mild (up to moderate) hearing loss

Issue:

The law limits use of OTC hearing aids to adults with “mild to moderate” hearing loss. Individuals who experience moderate or more severe hearing loss should seek support of a hearing care professional to obtain hearing aids.

Solution:

Limit access to OTC devices, to those individuals with mild (up to moderate) hearing loss. For simplicity, use ASHA’s classification of degree of hearing loss, as is the most used in the United States. ASHA defines a ‘mild to moderate’ hearing impairment as consistent with a hearing loss range of 26 to 55 dB.

LABELING:
Require easy to understand labeling appropriate for over the counter medical devices

Issue:

Outside-the-box labeling of OTC hearing aids will be a key source of information to support consumers to self-direct their own hearing care and to make knowledgeable decisions.

Solution:

Implement Congress’ mandate to define “requirement for appropriate labeling” including: statement that OTC hearing aids are medical devices intended for use only by adults (minimum age 18) with specified level of loss; 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.