Rehabilitation study with non-invasive bone conductive hearing aids in patients with otosclerosis and stapes anchylosis

• Conditions: H80.1; H90.1; Otosclerosis involving oval window, obliterative; Conductive hearing loss, unilateral with unrestricted hearing on the contralateral side

• Registration Number: DRKS00029943
• Lead Sponsor: Helios Center for Research and Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients for stapes surgery
-adults, able to consent
-unilateral or bilateral maximal air-bone-gap due to otosclerosis
-pure conduction hearing loss
-negative Rinne-test
-no previous ear surgery
-no skin problems and intact skin behind the ear
-no plaster allergy

Exclusion Criteria

-patients with no indication for stapes surgery
-patients under 18 years of age or who can not give consent for surgery
-pregnant patients
-skin problems especially behind the ear
-plaster allergy
-previous ear surgery
-inner ear otosclerosis with combined hearing loss

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the degree of efficacy of the ADHEAR bone anchored hearing aids in patients with otosclerosis and stapes ankylosis.

Secondary Outcome Measures

Name	Time	Method
Comparison of hearing performance between ADHEAR preoperative versus postoperative results 3 month after stapes surgery.