A prospective multicenter study to prove the efficacy of active bone-conduction implant in adult patients with single-sided deafness
- Conditions
- Diseases of the ear and mastoid process
- Registration Number
- KCT0005517
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed signi?cant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were signi?cantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a signi?cant factor of subjective bene?t (-11.643; 95% con?dence interval: -21.946 to -1.340). The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with longterm deafness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
(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.
(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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pure-tone thresholds;Speech discrimination score
- Secondary Outcome Measures
Name Time Method Bern Benefit in Single-Sided Deafness questionnaire (BBSS);Abbreviated Profile of Hearing Aid Benefit (APHAB);Tinnitus Handicap Inventory (THI)