Bone conductive hearing aid implantation.

Phase 1

• Conditions: Conductive hearing loss or Mixed hearing loss (bilateral or unilateral).

• Registration Number: JPRN-jRCTs032190003
• Lead Sponsor: Suzuki Hiroaki

Brief Summary

In this study, we treated one patient with congenital bilateral microtia and atresia, and one patient with congenital unilateral atresia by using BONEBRIDGE. As a result, the hearing thresholds for both patients improved dramatically after BONEBRIDGE fitting. Monosyllable perception score in noise condition was improved in one patient.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-02
• Study Completion: 2021-04-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2

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 5 years old or above.

Audiometric inclusion criteria
1)Unilateral or bilateral conductive hearing loss or mixed hearing loss.
2)Patient affected ear fulfill the below bone conduction hearing thresholds.
The patients with bone conducting hearing thresholds in 500Hz to 4000Hz is under 45dBHL.

Exclusion Criteria

(1)The patients with severe bone malformation and did not have enough setting space for bone conductive implantation.
(2)The patients with un-compatible to general anesthesia.
(3)The Patients with post cochlear hearing loss.
(4)The patients with skin problem and did not ware audio processor.
(5)The patients who assessed unsuitable for this clinical research from medical doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The therapeutic effects are evaluated at 6 month after the BONEBRIDGE operation, using free field audiometry. In this test, marked recovery is defined as any recovery in the mean hearing level at the 500, 1000, 2000 and 4000Hz .

Secondary Outcome Measures

Name	Time	Method
The therapeutic effects are also evaluated at 12 month after the BONEBRIDGE operation, using Japanese speech discrimination test. In this test, marked recovery is defined as any increase than pre-ope discrimination score.