Patients with unilateral or bilateral auricular defects, including microtia who use the cartilage conduction hearing aid
Conditions
Interventions
Combined use of ear prosthesis who use the cartilage conduction hearing aid.
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must be seen by the Department of Otolaryngology at Keio University by September 30, 2024, who wish to purchase a cartilage conduction hearing aid and who wish to receive this study device and meet all of the following criteria. (1) Patients between 5 and 90 years of age; (2) Patients with unilateral or bilateral auricular defects, including microtia; (3) Patients with at least aided or unaided hearing threshold of less than 40 dB on a trichotomous basis (mean of thresholds at 500, 1000, and 2000 Hz); (4) Patients who wish to purchase a cartilage conduction hearing aid on at least one side (5) Patients who understand the nature of the study and have provided written consent from the patient or caregiver.
Exclusion criteria
Exclusion criteria: (1) Patients who have allergic reactions to cartilage conduction hearing aids, ear prostheses, adhesive agents, skin protectants, or removers; (2) Patients who have difficulty in performing pure tone audiometry and speech intelligibility tests; (3) When the principal investigator or sub-investigator judges that participation in this study is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| he effect on hearing function will be compared for each ear condition (without hearing aid, with cartilage conduction hearing aid only, or with cartilage conduction hearing aid and ear prosthesis). | — |
Countries
Japan
Contacts
Public ContactNaoki Oishi
Keio University Hospital Department of Otolaryngology-Head and Neck Surgery
Outcome results
None listed