NuHeara and Innerscope Partner to Expand Access to OTC Hearing Aid Market

Nuheara Limited (ASX:NUH), the maker of the HP Hearing PRO, has announce a partnership with InnerScope Hearing Technologies (OTCPink: INND) for the expansion of its US retail footprint from reportedly 300 points of sale to about 4,600 over the coming months, with US FDA cleared self-fit hearing aids now being manufactured to fulfill initial orders from Best Buy and other US retail customers.

The two companies have agreed to partner together to penetrate the US hearing aid market, creating and providing retail and technology solutions to build a strong market share in the over-the-counter (OTC) self-fit hearing aids segment.

According to Nuheara, their omnichannel marketing approach, including a distribution network of wholesale and retail partners, gives the ability to reach the estimated 70 million people in North America that currently need hearing help.

Headquartered in Roseville, California, InnerScope offers point-of-sale Hearing Screening Kiosks in over 100 independent US pharmacies with another 1,000 pharmacy locations by mid 2023, says Nuheara. In addition, InnerScope reportedly has product displays in some 1,500 Walmart Vision Centers, and in early 2023 will roll out freestanding displays across about 1,700 Rite Aid pharmacy stores.

This memorandum of understanding builds on Nuheara’s recent receipt of US Food and Drug Administration clearance for its Self-Fitting OTC Hearing Aid. Nuheara’s HP Hearing PRO is the first hearing aid to be cleared by the FDA for both 874.3325 self- fitting and the 800.30 OTC hearing aid classifications under a new product classification code “QUH”.

Nuheara will supply its FDA OTC certified hearing products to InnerScope (including the HP Hearing PRO) at an agreed wholesale price. In addition, in return for an agreed royalty fee or service fee, the Company will license its technology and clinical know-how to implement and support the adoption of Nuheara’s self-fit technology into InnerScope products for FDA self-fitting clearance.

InnerScope will reportedly market, at its cost, Nuheara OTC products into new and existing retail chains, including, but not limited to, Walmart, Rite Aid, and other pharmacy brands. InnerScope will also provide first-level customer and warranty support for Nuheara products sold via InnerScope’s sales channels. To retain retail chain exclusivity, InnerScope will need to meet minimum order quantities in defined time periods.

Innerscope develops and markets OTC hearing aids and related hearing healthcare products, hearing aid, and ear care products, and hearing treatment therapies. The company's founder, Matthew Moore, was involved in a 2016 fraud case that involved Moore's family business which was the second-largest seller of hearing aids in the Sacramento region at the time, according to a news report.

In October 2021, InnerScope purchased iHear Medical which was founded by Adnan Shennib—the original inventor of the what was to become the Lyric extended-wear hearing aid. With iHear, Shennib developed a self-fit hearing aid and the first FDA-cleared home hearing screener. iHear was also headed in 2018 by current NuHeara US President John Luna.

As previously announced in November 2022, initial orders were placed for Nuheara’s US FDA cleared self-fitting hearing aids from retailers and ecommerce partners for availability throughout the US. Having received US FDA clearance and ISO medical device quality certification, NuHeara says it is now manufacturing its HP Hearing PRO hearing aids expected to be shipped in late January or early February 2023 to these retail partners.