The objectives are to evaluate the degree of bilateral benefit gained from having a second implant with respect to speech perception, spatial hearing, and listening effort.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome will be the performance on the Amsterdam-Oldenburg Bilateral
Benefit Battery for cochlear implants (AO-BBB-ci) test battery. This test
battery evaluates the performance for speech perception in background noise
with a spatial separation between the sound sources, horizontal localization,
and listening effort.
Secondary outcome
Secondary outcome measures will be self-reported benefits in everyday listening
situations assessed with the Speech, Spatial and Qualities Hearing Scale (SSQ),
generic quality of life questionnaire scores (Health Utilities Index, HUI) and
disease specific quality of life questionnaire scores (Nijmegen Cochlear
Implant Questionnaire, NCIQ, and Tinnitus Handicap Inventory (THI).
Background summary
Normal-hearing listeners gain important benefits from having two ears. Users of
a MED-EL cochlear implant (CI) achieve high levels of spoken word recognition
when speech is presented in quiet. However, these users still experience
difficulty in the presence of competing sounds and are poor at identifying
where sounds come from. These limitations may be overcome, to some degree, by
providing an implant to both ears. This study will investigate bilateral versus
unilateral benefit in adults who are implanted with two MED-EL cochlear
implants sequentially.
Study objective
The objectives are to evaluate the degree of bilateral benefit gained from
having a second implant with respect to speech perception, spatial hearing, and
listening effort.
Study design
58 subjects with severe sensorineural hearing loss will be included in this
Randomized Controlled Trial (RCT). 24 subjects shall receive one implant at the
beginning of the study and a second implant after a period of two years at the
end of this study (Group U). 24 subjects shall receive 2 cochlear implants
sequentially, one upon inclusion and one 6 months after the first implantation
(Group B). 10 subjects receiving a cochlear implant unilaterally that do not
wish to participate in this study but do fulfil all other inclusion criteria
and do not fulfil any of the exclusion criteria will be asked to complete all
study questionnaires and will be used as a reference group (Group R).
Intervention
Bilateral cochlear implantation.
Study burden and risks
For both groups, the risks of a second surgical procedure are considered equal
to the risks of the first surgery. When worsening of the health status of a
subject no longer allows a second surgery, the subject will be excluded from
further implantation. The evaluation consists of 6 or 7 test sessions of 2
hours each spread over a period of two years.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18.
2. Postlingual onset of hearing loss, defined as an onset of hearing loss >= 6 years of age.
3. Sensorineural hearing loss of a severe or greater degree in both ears, defined as pure tone average (250, 500, 1000, 2000 Hz) >= 70 dB HL with no signs of a ski-slope audiogram.
4. Duration of severe-to-profound hearing loss <= 20 years in each ear and a comparable duration of severe-to profound hearing loss between both ears.
5. No signs of asymmetry > 30 dB in the past year.
6. Marginal hearing aid benefit with hearing aids, defined as speech perception <= 60% at 65 dB SPL upon optimal hearing aid fitting.
7. Dutch language proficiency.
8. Willingness and ability to participate in all scheduled procedures outlined in the protocol.
9. General health allowing general anaesthesia during two sequential surgical procedures to implant both cochlear implants.
10. Adequate coverage of one cochlear implant by a patient*s Dutch health insurance company.
11. Willingness to be implanted with cochlear implants from MED-EL.
Exclusion criteria
1. Previous implant experience.
2. Disability which could interfere with the completion of all tests.
3. Abnormal cochlear anatomy in one or both ears.
4. Chronic ear infection in one or both ears.
5. Psychosocial contraindication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35640.018.11 |