Tag: 2015 hearing aid sales

All

Latest

OTC Hearing Aid Consensus Statement Published by AAA, ADA, IHS, and ASHA

The unprecedented consensus statement from four national hearing care professional organizations recommends the new FDA classification be called "Self-fit OTC hearing devices." The paper recommends the new class be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one 510(k) filing for initial FDA approval to ensure the basic safety and efficacy of the device.

All

Latest
Sorry, No Posts Found

All

Latest
Sorry, No Posts Found
Sorry, No Posts Found