Bone Anchored Hearing Implants in Chronic Otitis Media

Completed

• Conditions: Hearing
• Interventions: Device: Bone-anchored hearing implants

• Registration Number: NCT06047639
• Lead Sponsor: Pamukkale University

Brief Summary

The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in chronic otitis media patients

Detailed Description

Hearing loss is a significant disability that disrupts an individual's communication with others and can have a profound impact on their social life and career. It can lead to social isolation, depression, anxiety, and even early dementia. Chronic otitis is one of the most important ear diseases that can cause hearing loss. Its treatment is surgical, but sometimes even after surgery, hearing rehabilitation is needed. In such cases, the first option is the use of hearing aids. Some patients may be unable to use hearing aids due to excessive ear canal clearance, recurrent ear infections, or outer ear canal problems. In such cases, bone-anchored hearing devices emerge as the most logical option, although they are more costly compared to regular hearing aids. The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in the context of our country

Study Timeline

• Study Start: 2020-08-08
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adults
• No difficulty in coming to the hospital for follow-up
• Ability to communicate and express oneself at a level sufficient to interact with researchers
• Having an indication for BAHI due to Chronic Otitis media

Exclusion Criteria

• Those with severe systemic illnesses (cancer, HIV, etc.)
• Psychiatric patients experiencing compliance issues with hearing tests
• Use of medication or medical devices that could affect the outcome of the study
• Patients who cannot adhere to regular follow-ups and do not use the device will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone Anchored Hearing Implants(BAHI) Patient	Bone-anchored hearing implants	Patients with chronic otitis media whose hearing could not corrected with surgery and also could not use conventional and got bone-anchored hearing implants as a standard of care were included.

Primary Outcome Measures

Name	Time	Method
World Health Organisation(WHO) Quality of Life Questionarie	One year	Standard question list about the general health and quality of life of the patient
free field hearing level	one year	Measuring hearing threshold with device on
Speech, Spatial and Qualities of Hearing Scale	One year	Subjective evaluation of the hearing by questionaries

Secondary Outcome Measures

Name	Time	Method
Cost Benefit of the intervention	on year	to calculate the health related expenses for the patient before and after the intervention

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey