PUBLISHER: Grand View Research | PRODUCT CODE: 1493295
PUBLISHER: Grand View Research | PRODUCT CODE: 1493295
The U.S. hearing aids market size is anticipated to reach USD 3.01 billion by 2030 and is growing at a CAGR of 5.7% during the forecast period, according to a new report by Grand View Research, Inc. This growth is attributable to the increasing adoption of technologically advanced hearing aid devices and the rising prevalence of hearing loss among the geriatric population in the country.
The U.S. population is aging faster than ever before, which is causing an increase in the number of adults with hearing loss. According to the National Council on Aging, Inc., hearing impairment affects approximately 60.7 million Americans aged 12 and older, with 15.5% of adults aged 20 and above experiencing some hearing loss. Among individuals aged 65 and older, 31.1% suffer from hearing loss, increasing to 40.3% among those aged 75 and older. Globally, around 70 million people have complete hearing loss, while studies suggest that 28.8 million American adults could benefit significantly from wearing hearing aids. However, despite the prevalence of hearing loss, only 16% of individuals aged 20-69 and 30% of those aged 70 and above have ever used a hearing aid. Moreover, hearing loss rates in the United States are projected to nearly double by 2060.
The healthcare industry has become subject to increasing regulatory scrutiny, and one recent development is the establishment of guidelines for over-the-counter (OTC) hearing aids by the U.S. Food and Drug Administration (FDA). Manufacturers of hearing aids must comply with regulations set forth by the FDA under the FD&C Act, covering device standards like adverse event reporting, labeling, and electronic product regulations. Notably, these regulations extend to OTC hearing aids, outlining criteria for labeling, performance, and design. The FD&C Act specifies sections such as 21 CFR 800.30 for OTC hearing aids and 21 CFR 801.422 for prescription hearing aids, ensuring adherence to labeling requirements. Adhering to these regulations guarantees the availability of safe and efficient hearing aids, promoting informed choices among consumers.