Mimi Health Hearing Test

Model HTS-01

Version of software 1.11.0

The Mimi Health Hearing Test (HTS-01) intended use is to provide audiometric hearing screenings as support for decisions in relation to the medical diagnosis of hearing health including hearing impairment and hearing-related disorders.

The device provides guided instruction for self-administered air-conduction testing by the consumer in a quiet or sound-controlled environment. By increasing access to hearing screening when compared to traditional audiometry, the use of HTS-01 may lead to earlier self-referral for comprehensive medical diagnostic evaluation of hearing status by a qualified health professional.

HTS-01 does not supersede or replace a decisive diagnosis by a qualified health professional, does not allow direct diagnosis and is not intended to be used for monitoring, treatment or alleviation of any disease or disability. A diagnostic evaluation should be pursued if concerns about hearing sensitivity persist, independent of test results generated by HTS-01.