Why “Good Audiology” is More Important than Ever

by Brian Taylor “Signal & Noise” is a bimonthly column by Brian Taylor, AuD. Recent FDA regulatory chatter concerning hearing aids,  combined with the rising availability of automated technology is making audiologists nervous – – and rightly so. It certainly seems plausible we are embarking on an era when the skills and expertise of the…

Read More

Regulation of Hearing Aids, part 4

The evolution of the hearing aid industry sketched out in parts 1-3 of this post series is that of a consumer product.  From hand to horn to telephone-like device, the hearing aid was developed and thought of by manufacturers and consumers alike as an appliance that boosted sound.  In that regard, hearing aids were a closer fit…

Read More

Regulation of Hearing Aids in the United States, part 1

Hearing aids are categorized as Class 1 or Class 2 medical devices by the Food and Drug Administration. The large majority of hearing aids are in the Class 1 category, which means they are exempted from the premarket notification and FDA clearance requirement. Hearing aid manufacturers are required to register their establishments and bring their…

Read More