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Bone Anchored Hearing Implants in Chronic Otitis Media

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ClinicalTrials.gov Identifier: NCT06047639
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Fazıl Necdet Ardıç, Pamukkale University

Study Description
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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

Condition or disease Intervention/treatment
Hearing Device: Bone-anchored hearing implants

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 Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media
Actual Study Start Date : August 8, 2020
Actual Primary Completion Date : February 1, 2024
Actual Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
surgically placed hearing device


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Cost Benefit of the intervention [ Time Frame: on year ]
    to calculate the health related expenses for the patient before and after the intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047639


Locations
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Turkey
Pamukkale University
Denizli, Turkey, 20070
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: Fazıl N Ardıç, MD Pamukkale University
More Information
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Responsible Party: Fazıl Necdet Ardıç, Head of department of Otolaryngology, Pamukkale University
ClinicalTrials.gov Identifier: NCT06047639    
Other Study ID Numbers: 14
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases