Earlens Shares FDA Historical Ruling on OTC Hearing Aids

Menlo Park CA – September 14th, 2022 

Earlens, a privately held medical technology company transforming the way people hear with a new class of non-surgical hearing technology, supports the FDA’s ruling to create a new category of Over the Counter (OTC) hearing aids. Hearing loss, a medical epidemic associated with dementia, depression and social isolation affects an estimated 30 million people in the United States. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention. While this new ruling may address a few of the barriers that impede the adoption of hearing aids such as perceived hearing benefit relative to price and access, it will not address the top two complaints of hearing aid users: understanding speech in background noise and sound quality. The new over the counter hearing aids work in the same way as the traditional hearing aids widely available by prescription today. They amplify sound through a tiny speaker in a limited bandwidth. Unlike traditional hearing aids, Earlens works with the natural hearing system by gently vibrating the eardrum via a tiny, custom-built lens, which delivers 2.5X the audible bandwidth of traditional hearing aids, resulting in significantly better speech understanding in noise and improved clarity.

“With the changing landscape in the hearing space, Earlens is well positioned to assist the many people that are dissatisfied with traditional air-conduction hearing aids, whether they are purchased through a dispenser or over the counter. Earlens’ differentiated technology and unique care model places highly trained hearing healthcare professionals at the forefront of hearing loss treatment. Earlens is committed to transforming the hearing experience for millions of people who suffer from hearing loss”, said Bill Facteau, Earlens President & Chief Executive Officer.