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Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids

NCT04919928 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-22

No results posted yet for this study

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 ear.

This randomised controlled trial can show the benefit in terms of better speech perception of the bimodal solution with CI to the poorest hearing ear compared to binaural hearing aids.

It can clarify if HAs users with insufficient HAs benefit will benefit from the bimodal solution when adding a CI to the poorer hearing ear in terms of better speech perception.

It can report the degree of perceived hearing handicap in bimodal CI-users versus bilateral HA-users by hearing -specific patient reported outcome measures (PROM) questionnaires.

And it can contribute to a specific cochlear implant candidacy criterion related to the transition from HA treatment to the CI treatment.

The purpose of this study is to determine if bimodal treatment with a hearing aid to the better hearing ear and CI to the poorer hearing ear increases the ability to understand speech and improve quality of life compared to patients that are treated with hearing aids only.

The benefit of bimodal fittings compared to the best possible bilateral HA treatment will be evaluated.

Conditions

  • Hearing Loss, Cochlear

Interventions

DEVICE

Cochlear Implant and Hearing aid in bimodal solution

Sixty adult participants with bilateral hearing aids (HA) referred for cochlear implantation (CI) will be included in the study. It will be patients who report limited benefit with appropriately fitted HAs in daily speech communication in quiet and in noise. The patients are depending on visual cues for successful communication. All the referred patients have potential optimal fitted HAs that are no longer sufficient to treat their hearing loss and to improve the daily communication. All the patients will then receive new replacement HAs with the ability to corporate with a CI for one month trial period. One month is considered as a sufficient adaptation period to new replacement HAs according to current clinical practice. Thirty individuals randomised to receive the intervention with CI to the poorest hearing ear.

DEVICE

Bilateral hearing aids

Thirty individuals randomised to the control group will continue use of the new replacement HAs another three months, thus in total of four months of use.

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Jesper H Schmidt, Consultant · Ear nose and throat department/Hearing-clinic Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-07-30
Completion
2025-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919928 on ClinicalTrials.gov