JPRN-jRCTs032190002
Completed
Phase 1
Clinical research of VSB for unilateral conductive or mixed hearing loss
Suzuki Hiroaki0 sites5 target enrollmentApril 2, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nilateral conductive hearing loss or Mixed hearing loss
- Sponsor
- Suzuki Hiroaki
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
In this study, we treated four patients with unilateral conductive or mixed hearing loss patients by using VSB. As a result, the hearing thresholds for all patients improved dramatically after VSB fitting from 67.2 dB HL to 25.6 dB HL. Monosyllable perception score in noise condition and sound localization score were also improved but did not show statistical significance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General inclusion criteria
- •1\)Written informed consent was obtained from patient (or their guardians if they are minor).
- •2\)The age of informed consent was 4 years old or above.
- •Audiometric inclusion criteria
- •1\)Unilateral conductive hearing loss or mixed hearing loss.
- •2\)Patient fulfill the below bone conduction hearing thresholds.
- •500Hz:45dB or less
- •1000Hz:50dB or less
- •2000Hz:65dB or less
- •4000Hz:65dB or less
Exclusion Criteria
- •1\) Patients with highly malformation of cochlear or temporal bones.
- •2\) Patients do not use general anesthesia.
Outcomes
Primary Outcomes
Not specified
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