Dive Brief:
- Nuheara has received 510(k) clearance for a self-fitting over-the-counter hearing aid, positioning it to bring the HP-branded product to market.
- HP, the personal computer maker, formed a manufacturing and supply deal with Nuheara almost two years ago. The pact positioned Nuheara-manufactured devices to come to market carrying HP branding.
- Nuheara will sell its OTC hearing aid, the HP Hearing PRO, for $699 at retailers including Best Buy, Crutchfield and Amazon, undercutting rival devices from companies such as Sony and the Bose partner Lexie Hearing, priced at $999.
Dive Insight:
Last month, the Food and Drug Administration’s final rule created a new market for OTC hearing aids, leading multiple companies with backgrounds in medtech and consumer electronics to enter the space. In a competitive field, Nuheara is betting that the combination of its technology and the HP brand, known for printers and computers, will enable its product to claim a slice of the market.
“The powerful combination of Nuheara’s technology and experience along with HP’s brand recognition in the U.S., will translate to consumer confidence in their purchase of the HP Hearing PRO in this new OTC hearing aid category. We are already seeing signs of this from the retailers, given the high level of initial orders received,” U.S.-based Nuheara CEO John Luna said in a statement.
Nuheara, which is headquartered in Perth, Australia, said the FDA clearance of its product as a “self-fitting air-conduction hearing aid, over the counter” has resulted in the unique product code, QUH. In a study, the company linked the device’s use of the Focus directional microphones to a 30% improvement in speech understanding in the presence of noise. Self-fitting is managed by the HP Hearing mobile application.
