suspected hearing los hearing loss
Conditions
Interventions
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) e
Diagnostic Techniques and Procedures
Sponsors
Fujiwara Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of hearing screening conducted with the investigational device compared with the reference examination (primary accuracy metrics). | — |
Contacts
Public ContactFujiwara
Kurashiki Central Hospital
Outcome results
None listed