No registrations found.
ID
Source
Brief title
Health condition
severe sensorineural hearing loss
ernstig perceptief gehoorverlies
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance on the STAR2 hearing test.
Secondary outcome
1. Performance on the Standard Dutch phoneme test, the Speech intelligibility test with spatially separated sources and the Crescent of sound test;
2. Self-reported benefits in everyday listening situations assessed with the SSQ;
3. Quality-of-life questionnaire scores;
4. Tinnitus questionnaire results.
Background summary
Brief summary:
This study will investigate bilateral versus unilateral benefit in adults who are implanted with two Bionic Ears either simultaneously or sequentially. The objective is to evaluate the degree of bilateral benefit gained from having a second implant. 48 Adult subjects with severe sensorineural hearing loss will be included in this Randomised Controlled Trial. Half of the group shall receive one implant at the beginning of the study and a second implant after a period of two years. The other half shall receive two cochlear implants simultaneously during one operation. Objective and subjective parameters will be measured during evaluation sessions pre-operatively, and 1 and 2 years after cochlear implantation.
Study objective
Normal-hearing listeners gain important benefits from having two ears. Users of a Bionic Ear achieve high levels of spoken word recognition when speech is presented in quiet. However they 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 Bionic Ears either simultaneously or sequentially.
Study design
1. Preoperatively;
2. 1 year post (first) implantation;
3. 2 years post (first) implantation;
4. In sequential implantation group: 1 and 2 years after second implantation.
Intervention
Simultaneous or sequential bilateral cochlear implantation.
Dept. of Otolaryngology
Room G02.531
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 75 516 44
y.e.smulders@umcutrecht.nl
Dept. of Otolaryngology
Room G02.531
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 75 516 44
y.e.smulders@umcutrecht.nl
Inclusion criteria
1. Age 18-75;
2. Postlingual onset of hearing loss;
3. Severe Sensorineural hearing loss;
4. Duration of severe hearing loss <20 years;
5. Marginal hearing aid benefit with hearing aids;
6. Dutch language proficiency;
7. Willingness and ability to participate in all scheduled procedures outlined in the protocol;
8. General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery;
9. Patients covered by the Dutch health insurance;
10. Patients should agree to be implanted with cochlear implants from Advanced Bionics.
Exclusion criteria
1. Previous implant experience;
2. Disability which could interfere with the completion of the tests;
3. Abnormal cochlear anatomy in one or both ears;
4. Chronic ear infection in one or both ears.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1625 |
| NTR-old | NTR1722 |
| CCMO | NL24990.018.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON33681 |