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Completed

NCT Number: NCT06047639

Bone Anchored Hearing Implants in Chronic Otitis Media

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone-anchored hearing implants

Device

surgically placed hearing device

Primary outcomes

  1. free field hearing level

    Time frame: one year

    Measuring hearing threshold with device on

  2. Speech, Spatial and Qualities of Hearing Scale

    Time frame: One year

    Subjective evaluation of the hearing by questionaries

  3. 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

Secondary outcomes

  1. Cost Benefit of the intervention

    Time frame: on year

    to calculate the health related expenses for the patient before and after the intervention

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.