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VSB for unilateral conductive or mixed hearing loss

Phase 1
Conditions
nilateral conductive hearing loss or Mixed hearing loss
Registration Number
JPRN-jRCTs032190002
Lead Sponsor
Suzuki Hiroaki
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
5
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The therapeutic effects are evaluated at 12 month after VSB surgery using free field audiometry. 20dB or more threshold recovery regarded as effective cases.
Secondary Outcome Measures
NameTimeMethod
Inner and after surgery safeness and adverse event in the observation period.
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