Clinical research of the bone conductive hearing system.

Suzuki Hiroaki0 sites2 target enrollmentApril 2, 2019

ConditionsConductive hearing loss or Mixed hearing loss (bilateral or unilateral).

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Conductive hearing loss or Mixed hearing loss (bilateral or unilateral).
Sponsor: Suzuki Hiroaki
Enrollment: 2
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

April 2, 2019

End Date

April 11, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Suzuki Hiroaki

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 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.