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.
Condition or disease | Intervention/treatment | Phase |
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Hearing Loss, Cochlear | Device: Cochlear Implant and Hearing aid in bimodal solution Device: Bilateral hearing aids | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids in Patients With Asymmetric Speech Identification Scores: a Randomised Controlled Trial |
Estimated Study Start Date : | October 1, 2021 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | July 1, 2024 |
Arm | Intervention/treatment |
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Experimental: Bimodal solution with cochlear implant and hearing aid (CI+HA)
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
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. |
Experimental: Bilateral new replacement Hearing Aids (HA+HA)
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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yeliz Jakobsen, cand.med. | +4530669135 | yeliz.jakobsen@rsyd.dk |
Study Director: | Jesper H Schmidt, Consultant | Ear nose and throat department/Hearing-clinic Odense University Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | May 20, 2021 | ||||
First Posted Date ICMJE | June 9, 2021 | ||||
Last Update Posted Date | June 30, 2021 | ||||
Estimated Study Start Date ICMJE | October 1, 2021 | ||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids | ||||
Official Title ICMJE | Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids in Patients With Asymmetric Speech Identification Scores: a Randomised Controlled Trial | ||||
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. |
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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 the ear considered for implantation and that the discrimination in the best-aided condition should be 60% or less. These criteria exclude many patients with asymmetrical hearing, as they have speech identification above 60% in the best-aided condition. It is necessary to investigate how patients with asymmetrical hearing can benefit from a cochlear implant in the poorer hearing ear compared to when bilaterally fitted with HAs. Furthermore, it is still unclear at which clinical relevant candidacy criterion the optimal transition from HA treatment to CI treatment in the bimodal solution occurs, as randomized studies comparing HA users and CI users do not exist. The purpose of this study is to provide clinicians with better evidence to determine if patients who benefit insufficiently from bilateral HA treatment and have a speech discrimination of the better hearing ear > 50% will benefit from a CI in the poorer hearing ear. Patients intended to include in the study will all be adults >18 years with hearing loss on both ears where cochlear implant will be considered as a treatment for the poorest hearing ear. All patients have used hearing aids on both ears for at least 1 year. The benefit of bimodal fittings compared to the best possible bilateral HA treatment is evaluated. Furthermore, it is investigated if this results in increased speech intelligibility and quality of life with a bimodal solution where a cochlear implant is used on the poorer hearing ear compared to either CI alone or bilateral hearing aids. 60 patients referred for cochlear implant at Odense University Hospital will receive new HAs that are fitted for one month. Then they will be randomized to either the intervention group with CI+HA (bimodal) or to the wait and see control group with continuous use of HA+HA (bilateral) for another three months. Participants will undergo stratified randomization depending on the hearing thresholds prior to CI surgery in the poorest hearing ear. To provide better evidence to determine if patients who benefit insufficiently from bilateral Hearing aid treatment and have a speech discrimination of the better hearing ear > 50% will benefit from a Cochlear implant in the poorer hearing ear. Patients randomized to the intervention group CI+HA will undergo surgery as soon as possible after randomization. The control group that will use the hearing aids for an additional three months, will also be offered the bimodal solution with CI to the poorer hearing ear after total of four months with HA+HA. Description of the cohort Inclusion criteria - Adults >18 years old. - Fluent in Danish, including reading and writing - Willing to participate in and to comply with all requirements of the protocol. - Post-lingual deafness and use one or two HAs. - Participants should have aidable hearing in the ear not considered for CI implantation - Self-reported HA use of at least eight hour per day for at least one year in both ears prior to evaluation for cochlear implantation in order to ensure, that both ears have received auditive stimulation prior to participation in the study. If possible, the validity of the self-reported hearing aid use will be checked in the HA-log by the audiology assistants. - Participants should have a PTA (0.5,1,2,4 kHz) > 40 dB HL in the ear considered for CI implantation and PTA≥40 and ≤ 70dB HL in the ear not considered for implantation. - A speech identification score Ethics approval for the conduct of this study was obtained from the Ethics Committee Southern Denmark. 21st August 2020. The trial will be conducted in compliance with this study protocol. All participants will undergo a process of informed consent and will be aware that participation is strictly voluntary. Participants may withdraw from the study at any time. The project is approved by the Danish Data Protection Agency (file no. 20/22868) in Region South Denmark which is an independent authority that supervises compliance with the rules on protection of personal data. ("paraplyanmeldelse" in danish). The study statistic analysis plan will be implemented as well. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hearing Loss, Cochlear | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 1, 2024 | ||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04919928 | ||||
Other Study ID Numbers ICMJE | 20/22868 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | University of Southern Denmark | ||||
Study Sponsor ICMJE | University of Southern Denmark | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Southern Denmark | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |