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…
ID
Bron
Verkorte titel
Aandoening
severe sensorineural hearing loss
ernstig perceptief gehoorverlies
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Performance on the STAR2 hearing test.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Simultaneous or sequential bilateral cochlear implantation.
Publiek
Dept. of Otolaryngology
Room G02.531
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 75 516 44
y.e.smulders@umcutrecht.nl
Wetenschappelijk
Dept. of Otolaryngology
Room G02.531
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88 75 516 44
y.e.smulders@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1625 |
| NTR-old | NTR1722 |
| CCMO | NL24990.018.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON33681 |