Medical Device Information
Quality Management System
Incus Company Limited operates an ISO 13485:2016 Quality Management System for Medical Devices certified by BSI with certificate number MD717362. The scope of the quality management system is "The design, development, sales and distribution of audiometer application for smartphone and television."
Incus Hearing Test
In Hong Kong S.A.R. and the United States, Incus Hearing Test is an audiometer application for smartphones intended for screening purposes.
It is listed as a Class II medical device with the United States Food and Drug Administration (FDA) with product code EWO. Incus Company Limited is a registered manufacturer with the FDA with registration number 3016965886.
It is currently not available outside Hong Kong S.A.R. and the United States.
Kite and Yinbei
Kite (including the Kite and Kite 2 models) is a smart personal sound amplifier. It is not a hearing aid, nor is it intended to replace a professionally fitted hearing device, except within the Hong Kong S.A.R..
Kite and Yinbei can be used to complete a hearing test. The hearing test in Yinbei is based on Incus Hearing Test technology, but it has not been developed as a medical device. This hearing test is not an audiometer, and the result is not a diagnosis. Any data or results from Yinbei are only intended for the purpose of personalising the audio from Kite.