Issue Statement from the American Academy of Audiology
January 26, 2017
If OTC devices are approved by law, the Academy recommends the following guidelines:
- The FDA should require any device marketed for hearing loss in a direct-to-consumer manner to meet specific acoustic and labeling conditions that are designed to protect the end-user.
- The devices should be described in a manner so as to avoid confusion with hearing aids that are regulated as medical devices by the FDA and are intended for use by both adults and children, for losses of greater degree than a mild degree, or for losses other than sensory type.
- The devices are labeled as intended for use by adults over the age of 18. Every effort should be made to assure these devices are not acquired or used by individuals under the age of 18 years except when dispensed or prescribed by a licensed audiologist.
- The devices should be labeled as intended for use by adults with mild hearing loss and with mild communicative impairments. Every effort should be made to assure these devices are not acquired or used by individuals with more severe forms of loss or impairment unless dispensed or prescribed by a licensed audiologist.
- The devices include explicit and easy-to-read directions for use, including cautions associated with long-term use.
- Devices should be labeled in a manner that allows the consumer to make comparisons between the devices.
- Standards for the acoustical characteristics should assure that the output of the devices does not exceed levels that could cause additional hearing loss or cause hearing loss in those with normal hearing.
- The red flag warning signs must be included with all labeling for products intended to manage hearing loss or communication deficits, and that indications for referral for an audiologic or otologic evaluation are noted.
- The labeling must include language that notes the devices are not intended to replace the advice or recommendation of a licensed audiologist and may not produce an equivalent benefit to individually prescribed and programmed devices.
- The labeling includes language that advises the user that better outcomes are achieved when:
- a comprehensive audiological examination is conducted prior to the acquisition of the device,
- otoscopy is completed prior to using to ensure that the ear canal is not occluded with cerumen, and
- the device is coupled with an individually designed audiologic rehabilitation program.
- The labeling includes language that states the devices are not intended to treat tinnitus, inner ear dizziness, or pain in the ears.
- The labeling includes the negative consequences of under fit or inappropriately treated hearing loss.