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Clinical Trials/NCT06047639
NCT06047639
Completed
N/A

Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media

Pamukkale University1 site in 1 country24 target enrollmentAugust 8, 2020
ConditionsHearing

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing
Sponsor
Pamukkale University
Enrollment
24
Locations
1
Primary Endpoint
World Health Organisation(WHO) Quality of Life Questionarie
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
August 8, 2020
End Date
March 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fazıl Necdet Ardıç

Head of department of Otolaryngology

Pamukkale University

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

World Health Organisation(WHO) Quality of Life Questionarie

Time Frame: One year

Standard question list about the general health and quality of life of the patient

free field hearing level

Time Frame: one year

Measuring hearing threshold with device on

Speech, Spatial and Qualities of Hearing Scale

Time Frame: One year

Subjective evaluation of the hearing by questionaries

Secondary Outcomes

  • Cost Benefit of the intervention(on year)

Study Sites (1)

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