HearingNCT06047639
Bone Anchored Hearing Implants in Chronic Otitis Media
An observational study of Hearing, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing
- What is being tested?
- Bone-anchored hearing implants
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of 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
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
- Conditions
- Hearing
- Being tested
- Bone-anchored hearing implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-anchored hearing implantsDevice
surgically placed hearing device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bone-anchored hearing implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
free field hearing level
Measuring hearing threshold with device on
Measured: one year
Speech, Spatial and Qualities of Hearing Scale
Subjective evaluation of the hearing by questionaries
Measured: One year
World Health Organisation(WHO) Quality of Life Questionarie
Standard question list about the general health and quality of life of the patient
Measured: One year
Secondary outcomes (1)
Cost Benefit of the intervention
to calculate the health related expenses for the patient before and after the intervention
Measured: on year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Aug 2020
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HearingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047639
- Sponsor's protocol ID
- 14
- Status last verified
- May 2024
- First submitted
- 14 Sep 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media
- ClinicalTrials.gov ID
- NCT06047639
- Acronym / sponsor ID
- 14
- Conditions
- Hearing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Anchored Hearing Implants(BAHI) Patient | – | Device: Bone-anchored hearing implantsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone-anchored hearing implantssurgically placed hearing device | Device | Bone Anchored Hearing Implants(BAHI) Patient |
Primary outcome
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
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
1 secondary outcome
Cost Benefit of the intervention
Time frame: on year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fazıl N Ardıç, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
free field hearing level (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.