Bose Hearing Aids that are expected to be introduced for sale, look nearly identical to their last hearing-assistive product, the Bose “Hearphones”. (left below photo)The Bose Hearing Aid is the first FDA-approved hearing aid in a new category of products known as “self-fitting air-conduction hearing aids.” (right photo)
Right photo is FDA Filing): Bose Hearphones (Source – Hearphones User Manual)
The FDA’s summary of the Bose hearing aid followed the October approval of the company’s “De Novo” application for the newhearing aid. In addition to providing a detailed description of the product, it says clinical findings demonstrate the Bose self-fitting hearing aid “provides performance benefit consistent with that of the same hearing aid fitted by hearing aid professionals.”
The Bose Hearing Aid provides performance benefits consistent with that of the same hearing aid fitted by hearing aid professionals for individuals ages 18 and older with mild to moderate hearing loss, according to the FDA Summary
New category of self-fitting hearing aids
According to the FDA, the Bose self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
A self-fitting air-conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.FDA Summary
Although the latest FDA documentation clears the way for Bose to sell its new Hearing Aid, the company has not yet said when it plans to go to market.
Hearing-aid earbuds attached to a flexible neckband packed with electronics
The Bose Hearing Aid looks like the popular Bose Hearphones, with a flexible neckband housing a rechargeable lithium-ion battery and electronic components with extending cables for the right and left ears. Earbuds are connected to the neckband by flexible wires, with an ear-tip mounted on each earbud. Three sizes of tips are packaged with the product so that the user can choose the optimal size.
The Hearing Aid has two microphones in each earbud that may be configured in omnidirectional or directional modes to enhance understanding of speech in noise. Active noise reduction using “feedback and feedforward control loops” reduces environmental sounds, with power from a rechargeable 3.7 V, 250 mAh lithium-ion battery pack.
Like the Hearphones, the Bose Hearing Aid will feature Bluetooth audio streaming from smartphones, for both music and phone calls.
Self-fitting software with mobile “Bose Hear” smartphone app
The Bose Hear mobile smartphone app works with both iPhones and Android smartphones. Bose Hearphones users will find familiar device configurations including “World Volume” and “Treble/Bass” gain settings. The settings are preserved between use sessions and the settings from the previous session are recalled upon power-up of the device.
Screenshots from the Bose Hear App for Bose Hearphones
A set of manual buttons located on one of the cables from the neckband can also be used to adjust both the “World Volume” and directional mode.
Hearing Aid Features
Hearing aid signal processing includes 12-channel wide dynamic range compression amplification with compression thresholds fixed at speech-equivalent 52 decibels (dB) sound pressure level (SPL). Noise reduction is continuously active, lessening environmental noise and decreasing amplification of the user’s own voice.
Additional features include:
- Feedback cancellation
- Steady state noise reduction
- Directionality (three modes controllable by user)
- Impulse noise control
- Left/Right balance
- Bluetooth-compliant 2.4 GHz wireless radio for streaming audio, telephony, and control
- Microphone array to help clarify voices on phone calls
- Volume-optimized audio equalization (selectable high-frequency boost when listening to streamed content)
- Voice prompts
- Battery life of approximately 10 hours
- NFC pairing for compatible Android devices
Clinical tests satisfy FDA that self-fitting software works
A human-factors study, non-clinical bench tests, and two clinical studies satisfied the FDA that the Bose Hearing Aid will be safely deliver on the promise of self-fitting software for people with mild-to-moderate hearing loss.
Among two groups of users, one with a professional fitting and one that used the self-fit software, the studies concluded that: Subjects in the self-fit group were satisfied with (or preferred) their own settings to the professionally-selected settings more than were/did subjects in the professionally fit group.
The subjects in the self-fit group rated themselves significantly happier with the sound quality than did those in the pro-fit group.
There was no difference in speech intelligibility benefit between the self-fit and pro-fit groups.
The report concludes that the clinical data support the claim that the Bose self-fitting hearing aid “provides performance benefit consistent with that of the same hearing aid fitted by hearing professionals for individuals ages 18 and older with mild to moderate hearing loss.”