Bone Anchored Hearing Implants in Chronic Otitis Media

NCT ID: NCT06047639

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-08

Study Completion Date

2024-03-01

Brief Summary

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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

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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

Conditions

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Hearing

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone Anchored Hearing Implants(BAHI) Patient

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.

Bone-anchored hearing implants

Intervention Type DEVICE

surgically placed hearing device

Interventions

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Bone-anchored hearing implants

surgically placed hearing device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Fazıl Necdet Ardıç

Head of department of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fazıl N Ardıç, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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14

Identifier Type: -

Identifier Source: org_study_id

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