(13 pages) 13 organizations submitted comments for the Food and Drug Administration’s (FDA) Notice of Proposed Rulemaking Establishing Over-the-Counter Hearing Aids.
“HLAA and the undersigned organizations recommend the FDA require labeling that provides information about connectivity options for both over-the-counter and prescription hearing aids for all modes of wireless connectivity supported by the device (e.g., telecoil, Bluetooth, etc.).
The following is example language. The exact language used would depend on the type of technology available for connectivity. By simply stating all modes of connectivity supported by the device, future technology developments in the area of audio connectivity can easily be accommodated.
- This device is Bluetooth enabled for audio connectivity.
- This device contains a telecoil for audio connectivity.”
“We believe it is important to be transparent about the status of a hearing aid’s RF (Radio Frequency) immunity for wireless device compatibility for both OTC hearing aids and prescription hearing aids. RF immunity should be tested and reported in accordance with ANSI C63.19-2019–in both microphone (M) and, if present, telecoil (T) coupling modes. The information should be readily apparent to the consumer by having this information outside the package, inside the package and online.”
