Nuheara Limited welcomed the US Food and Drug Administration's final ruling, establishing a regulatory category for over-the-counter (OTC) Hearing Aids in the United States. In a world first, and most significantly for Nuheara, the ruling allows hearing aids within the OTC category to be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist. There is now a 60-day enactment period until the commencement of OTC hearing aid consumer retail sales are allowed, anticipated for mid-October 2022.

The US FDA received over 1,000 public comment submissions on the proposed rule change. The majority of submissions reflected that American people and healthcare professionals agreed on the significant positive impact that OTC hearing aids could have. The public comments also revealed, as expected, that the dominant hearing aid manufacturers strongly opposed the proposed rule, including using industry-funded "astroturf" campaigns intended to distort public opinion.

Despite the incumbent hearing aid manufacturers' efforts to jeopardise such an important ruling, the FDA formally ruled in favourof the OTC category for hearing aids. This historical rule change will forever upend the hearing aid industry and unlock historical barriers to entry for the estimated 38 million Americans who experience some hearing loss. Currently in the US, hearing aids are sold at an average cost of USD 4,726 per pair and can be as much as USD 10,000 or more per pair through licensed audiologist and licensed hearing aid retailers.

Now, with the ability for those with perceived mild to moderate hearing loss to purchase OTC, this cost could come down lower than USD 1,000 per pair of hearing aids.