NIPH Clinical Trials Search

A Study to Check How Accurate an App Is for Detecting Hearing Loss in Adults

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	suspected hearing los
Date of first enrollment	02/02/2026
Target sample size	200
Countries of recruitment
Study type	Interventional
Intervention(s)	The hearing screening test using the investigational device (KCH-01) will be performed. This test is conducted to evaluate its diagnostic performance in comparison with the reference (gold-standard) examination.

Outcome(s)

Primary Outcome	Diagnostic performance of hearing screening conducted with the investigational device compared with the reference examination (primary accuracy metrics).
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 40age old
Age maximum	<= 79age old
Gender	Both
Include criteria	Patients aged 40 to 79 years at the time of obtaining informed consent. Patients who have provided written informed consent. Patients who are proficient in Japanese and able to follow test instructions. Patients who have visited the study site within the past year.
Exclude criteria	Patients with active otorrhea. Patients with congenital or acquired deformities of the external ear. Patients who cannot understand spoken language unless the speaker's mouth is in contact with the auricle.