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CompletedNCT06047639Updated May 3, 2024

Bone Anchored Hearing Implants in Chronic Otitis Media

An observational study in Hearing, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Pamukkale University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Hearing

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03

In context

Otitis Media

284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.

This study's enrollment of 24 is below the median of 155 across 72 observational studies indexed under Otitis Media.

Browse Otitis Media studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Bone-anchored hearing implants

Interventions

  • DeviceBone-anchored hearing implants

    surgically placed hearing device

06

What researchers measure

Primary outcomes

  1. free field hearing level

    Measuring hearing threshold with device on

    Time frame: one year

  2. Speech, Spatial and Qualities of Hearing Scale

    Subjective evaluation of the hearing by questionaries

    Time frame: One year

  3. World Health Organisation(WHO) Quality of Life Questionarie

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

    Time frame: One year

Secondary outcomes

  1. Cost Benefit of the intervention

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

    Time frame: on year

07

Study locations

1 site
  • Pamukkale University
    Denizli, 20070, Turkey
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06047639
Lead sponsor
Pamukkale University
Responsible party
Fazıl Necdet Ardıç (Head of department of Otolaryngology, Pamukkale University) — Principal investigator
First posted
Sep 21, 2023
Start date
Aug 8, 2020
Primary completion
Feb 1, 2024
Completion
Mar 1, 2024
Last update
May 3, 2024

Study contacts

Fazıl N Ardıç, MD
principal investigator · Pamukkale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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