Connecticut Attorney General William Tong announced four separate settlements with hearing aid companies: Lively Hearing Corporation, Widex USA, Inc., Hark Wellness, Inc., and Wonder Ear, Inc., who marketed their products as “FDA-approved” despite no such approval.
Hearing aids currently do not receive approval from the United States Food and Drug Administration (FDA) in the same manner as new drugs and some medical devices; however, hearing aid manufacturers register their products with the FDA.
Although Congress enacted legislation in 2017 permitting the FDA to create a category of over-the-counter (OTC) hearing aids, the FDA has not yet issued a final rule and no hearing aid suppliers should be marketing their products as OTC or “FDA-approved.”
Recent Posts
ASLP-IC Readies for Rollout: Here’s What You Need to Know
The Audiology and Speech-Language Pathology Interstate Compact (ASLP-IC) continues to move toward full implementation, expanding opportunities for audiologists and speech-language pathologists to practice across state…
How Do Animals Perceive Music?
Music can be defined as vocal, instrumental, or mechanical sounds, with rhythm, melody or harmony, and often, an expression of human emotion. Music can transcend…
‘Eye’ on Health: AI Detects Dizziness and Balance Disorders Remotely
Interesting research led by audiologist Ali Danesh, PhD, at Florida Atlantic University (FAU) helped develop a novel, proof-of-concept tool to help identify nystagmus using a…