PSAP, Amplifiers, Hearing Aids...Oh My! Where to start, right? Let’s start with what you really came here to find out-- Yes, Eargos are hearing aids: Exempt medical devices registered with the FDA and are subject to FDA regulations on standards for performance, manufacturing, labeling and safety.
Hearing aids amplify sounds at specific frequencies to compensate for hearing loss. The amplification is dependent on how loud the sound is and uses algorithms to decide how much output to deliver to your ear. Hearing aids amplify soft sounds more and loud sounds less. They reduce background noise, preserve speech and can cancel whistling or feedback.
So yes, you will hear things amplified with a hearing aid but this does not mean they are an “amplifier.” Amplifiers amplify all sounds equally. Amplifiers are classified by the FDA as Personal Sound Amplification Products (PSAP), and are defined as a "wearable electronic product not intended to compensate for impaired hearing." They are general amplifiers that make everything louder and do not have to meet the same standards as hearing aids. By their definition, PSAPs are meant to amplify environmental sounds for “non-hearing-impaired” consumers.
The FDA defines a hearing aid as a sound-amplifying device intended to compensate for impaired hearing. Eargo SE, Eargo 7, Eargo 6 and Eargo 5 hearing aids are FDA Registered Class II medical devices. Additionally, these devices are cleared as self-fitting hearing aids per K221698. Link by Eargo is an FDA Registered Class II Exempt medical device. Link by Eargo is not self-fitting. This means that Eargo has submitted data to FDA for review and clearance prior to marketing these devices. This means we’ve taken the necessary steps to make sure our devices meet specific standards and criteria, these are the same guidelines that all traditional hearing aid brands have to meet. Eargo is designed by an ENT doctor with more than 30 years experience and rigorously tested by a team of audiologists and talented engineers whose sole focus is designing leading-edge solutions.