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

NCT04919928 | Unknown DMC

• 1 other identifier: 20/22868
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• Hearing in Noise Test (HINT) Speech identification scores

  Speech identification scores measured by Hearing in Noise Test (HINT). 1-100% higher is better

  1 hour

• Speech Spatial Questionnaire (SSQ-12)

  Patient reported outcomes measured by Speech Spatial Questionnaire (SSQ-12). 1-10, higher is better.

  1 hour

Secondary Outcomes (6)

• Dantale I

  1 hour

• Nijmegen Cochlear Implant Questionnaire (NCIQ)

  1 hour

• Tinnitus Handicap Inventory (THI)

  1 hour

• Dizziness Handicap Inventory (DHI) Patient reported outcomes measures

  1 hour

• Peak pupil dilation (PPD)

  half an hour

Study Arms (2)

Bimodal solution with cochlear implant and hearing aid (CI+HA)

EXPERIMENTAL

This Arm will serve as the intervention group. Patients referred for evaluation of cochlear implant candidacy at Odense University Hospital will be screened for eligibility in this study and invited to participate. All patients receive new replacement HAs that can later be fitted with the CI in a bimodal solution. The patients will use the new replacement HAs for one month and are then randomized to either the intervention group with CI+HA or to the control group with continuous use of HA+HA (bilateral) for another two months. Patients randomized to the intervention group CI+HA will undergo surgery as soon as possible after randomization. Patients with the bimodal solution CI+HA will undergo follow-up one, three, six and twelve months after CI fitting.

Device: Cochlear Implant and Hearing aid in bimodal solution

Bilateral new replacement Hearing Aids (HA+HA)

EXPERIMENTAL

This Arm will serve as the control group. The patients in the control group will use the new replacement HAs for one month like the intervention group and then for another three months, if they complete the study. The control group using the new replacement HAs for three months after randomization, will be offered the bimodal solution with CI to the poorer hearing ear and have the same follow-up period as the intervention group after a total of four months with new replacement HAs.

Device: Bilateral hearing aids

Interventions

Cochlear Implant and Hearing aid in bimodal solution DEVICE

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.

Bimodal solution with cochlear implant and hearing aid (CI+HA)

Bilateral hearing aids DEVICE

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.

Bilateral new replacement Hearing Aids (HA+HA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Ear nose and throat department/Hearing-clinic Odense University Hospital

Odense, Southern Denmark, 5000, Denmark

RECRUITING

Related Publications (1)

• Jakobsen Y, Christensen Andersen LA, Schmidt JH. Study protocol for a randomised controlled trial evaluating the benefits from bimodal solution with cochlear implant and hearing aid versus bilateral hearing aids in patients with asymmetric speech identification scores. BMJ Open. 2022 Dec 29;12(12):e070296. doi: 10.1136/bmjopen-2022-070296.

  PMID: 36581413 DERIVED

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implants; Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Sensory Aids; Wearable Electronic Devices

Study Officials

• Jesper H Schmidt, Consultant

  Ear nose and throat department/Hearing-clinic Odense University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yeliz Jakobsen, cand.med.

CONTACT

+4530669135; yeliz.jakobsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 9, 2021
• Study Start: February 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: January 31, 2025
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It is available

Locations

DK (1)