None listed
Conditions
Interventions
Medical Device : Implantation of active bone-conduction hearing aid through the surgery.
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Unilateral sensorineural hearing loss patients = 19 years of age (2) Air-conductive hearing thresholds at the weighted four-frequency (500, 1000, 2000, and 4000 Hz) average = 70 dB and bone-conductive hearing thresholds at the weighted four frequency average = 30 dB (3) Difficult to expect the improvement of hearing by the use of conventional hearing aids (4) No contraindication to general or local anesthesia (5) Subjects must voluntarily consented to participate in the clinical study and signed the consent form.
Exclusion criteria
Exclusion criteria: (1) Those who cannot read the consent form (for example, illiterate or foreigner) or who cannot understand the clinical study due to intellectual disabilities (2) If the hearing loss period is short and there is a possibility of spontaneous recovery, such as sudden sensorineural hearing loss (3) If a subject is being administered a drug that may affect the hearing or has a systemic disease that may cause hearing impairment (4) Judged to be inappropriate for this clinical study by the investigators of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pure-tone thresholds;Speech discrimination score | — |
Secondary
| Measure | Time frame |
|---|---|
| Bern Benefit in Single-Sided Deafness questionnaire (BBSS);Abbreviated Profile of Hearing Aid Benefit (APHAB);Tinnitus Handicap Inventory (THI) | — |
Countries
Korea, Republic of
Contacts
Public ContactHantai Kim
Ajou University Hospital
Outcome results
None listed