Status:
UNKNOWN
Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids
Lead Sponsor:
University of Southern Denmark
Conditions:
Hearing Loss, Cochlear
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hearing-aid (HA) users with insufficient HA may be better helped with a "Bimodal solution" when replacing the HA with a Cochlear implant (CI) to the poorer hearing ear and a HA to the better hearing e...
Detailed Description
Cochlear implants (CI) have been used to restore hearing in individuals with severe to profound sensorineural hearing loss. Normally, it is required that speech identification scores are below 50% in ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adults \>18 years old.
- Fluent in Danish, including reading and writing
- Acquired post-lingual deafness
- Use of bilateral HAs for at least one year prior to evaluation for cochlear implantation candidacy. This to ensure, that both ears have received auditive stimulation
- PTA \> 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the contralateral ear in best aided condition, in quiet and in noise and in free field.
- SIS \<70% in best aided condition in the ear considered for CI implantation and SIS ≥30% and ≤70% in best aided condition in the contralateral ear, in quiet and in noise and in free field.
- Exclusion Criteria
- Vestibular loss in the ear not considered for CI implantation
- Surgical issues interfering with the site of implantation or anatomical contraindications such as cochlear malformations, which will be determined using MRI or CT-scans.
- Auditory nerve lesions.
- Central auditory pathway pathologies.
- Otosclerosis.
- Single sided deafness (SSD).
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04919928
Start Date
February 1 2022
End Date
January 31 2025
Last Update
November 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ear nose and throat department/Hearing-clinic Odense University Hospital
Odense, Southern Denmark, Denmark, 5000