Nuance Audio Hearing Aid Software

The Nuance Audio Hearing Aid Software is a software-only mobile application designed to amplify sound for adults 18 years and older with perceived mild to moderate hearing loss. It operates on compatible smart glasses (Nuance Audio Glasses) and uses four preset fitting options based on validated hearing loss profiles, allowing users to self-fit without professional assistance. The device is intended for over-the-counter use.

The subject device uses smart glasses with temple-mounted microphones and speakers delivering open-ear-canal amplification, whereas the predicate (Apple HAF) uses in-ear earbuds. The subject device employs preset fitting with four predetermined audiogram profiles, while the predicate uses self-fitting with user-provided audiogram input. Both use wide dynamic range compression, rechargeable lithium-ion batteries with ~6-hour life, active noise reduction, and mobile app control. The subject device has 8.8 ms latency and 200-6300 Hz frequency response compared to the predicate's 3.15 ms and 100-10,000 Hz.

ISO 10993 series (biocompatibility); ANSI/ASA S3.22-2014 and CTA 2051:2017 (electro-acoustic measurements); IEC 60601-1, 60601-1-2, and 60601-2-66 (electrical safety and EMC); IEC 62304 (software lifecycle); ISO 15223-1:2021 (labeling); IEC 62366:2015 (human factors/usability).

Both devices have identical intended use (amplification for adults with perceived mild-to-moderate hearing loss without professional fitting) and same regulatory classification. Although they differ in wearable form factor (smart glasses vs. earbuds) and fitting method (preset vs. self-fitting), performance testing shows the subject device meets the same electro-acoustic specifications and clinical outcomes. Real-ear insertion gain testing showed subject device within 5 dB of predicate at most frequencies and within ±6 dB of NAL-NL2 targets. Speech-in-noise improvements and patient-reported outcomes (IOI-HA) demonstrated clinical effectiveness equivalent to the target population's needs, demonstrating these technological differences do not raise different safety or effectiveness questions.