Short summary

Hearing-aid (HA) users with insufficient HA may be better helped with a bimodal solution when adding a CI to the poorer hearing ear. This is in order to support and strengthen the preoperative clinical decision regarding continuous use of optimally fitted HAs compared to a bimodal solution and the perceived quality of hearing and quality of life that bimodal patients report.

The main question of the study is to prove if bimodal solutions (CI+HA) with CI on the poorest hearing ear and a HA on the better hearing ear are superior to HAs alone (HA+HA) in a randomized control trial.

Rationale

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, and increased music perception of rhythm and possibly tones 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 two months. 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. 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. Participants will be randomized in blocks 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.

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

Data and biological material

Measurements and survey data

- Audiogram, pupillometry, HINT-tests

- Questionnaires.

Collaborating researchers and departments

Department of Audiology, Odense University Hospital

• Resident, PhD-fellow Yeliz Jakobsen