Disclaimer

Terms of Service for using Mimi Health Hearing Test (HTS-01): https://mimi.health/terms-of-service. By using Mimi Health Hearing Test (HTS-01), you confirm that you are of the required minimum age and legal capacity and you consent to the Terms of Service. 

You can access the User Manual for Mimi Health Hearing Test (HTS-01) here: https://mimi.health/hts-01/user-manual. You can access the Label for Mimi Health Hearing Test (HTS-01) here: https://mimi.health/hts-01/label

Mimi Health Hearing Test (HTS-01) is a Class I medical device with CE marking in the European Union.

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.

Mimi Health GmbH is the manufacturer of the Mimi Health Hearing Test (HTS-01) and not the partner host application.

Intended end users of HTS-01 are laypeople 18 years and older, who desire to perform a mobile hearing test in order to screen their general hearing sensitivity and are sufficiently experienced with and capable of successfully operating a smartphone or tablet in order to use HTS-01 inside a partner mobile application. Intended users are expected to be proficient at interacting with touch screen applications without professional training in technology or healthcare industries.

HTS-01 targets users with mild to moderate hearing loss as well as users that do not have any hearing loss or deterioration in their hearing health, but want to learn more about their hearing abilities. Individuals with suspected or documented severe to profound hearing loss are excluded from the intended target population of HTS-01 because maximum sound pressure level (SPL) output limitations on most consumer electronic devices would preclude an accurate assessment.

The legal manufacturer of the Mimi Health Hearing Test (HTS-01) is Mimi Health GmbH (https://mimi.health/imprint).In case you have a complaint associated with the Mimi Health Hearing Test (HTS-01), please contact us at hello@mimi.health. Mimi Health Hearing Test (HTS-01) is not certified by the FDA.