Bone Anchored Hearing Implants in Chronic Otitis Media

Hearing Clinical Trial

Official title:

Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06047639
• Other study ID #: 14
• Status: Completed
• Start date: August 8, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing
• Otitis Media

Intervention

Device:
• Bone-anchored hearing implants
surgically placed hearing device

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free field hearing level	Measuring hearing threshold with device on	one year
Primary	Speech, Spatial and Qualities of Hearing Scale	Subjective evaluation of the hearing by questionaries	One year
Primary	World Health Organisation(WHO) Quality of Life Questionarie	Standard question list about the general health and quality of life of the patient	One year
Secondary	Cost Benefit of the intervention	to calculate the health related expenses for the patient before and after the intervention	on year