Trials / Completed
CompletedNCT02966379
Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Oticon Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead. The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
Detailed description
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. Literature showed the EAS stimulation can lead to better speech understanding, especially in noisy situation, and can provide important information about intonating or melodic contours, thus increasing sound quality and music perception. Objectives The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead. The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor. Methods Unaided tonal audiograms are measured for cochlear implant candidates with low frequency residual hearing before and after cochlear implantation with the EVO electrode lead. Aided tonal audiograms and speech intelligibility in quiet and in noise are measured after implantation with the three modes of stimulation (acoustic stimulation AS, electric stimulation ES, and electro-acoustic stimulation EAS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cochlear implantation | Surgery is standardized in order to have the same procedure for all patients and to preserve a maximum of residual hearing: * Corticosteroïds (1mg/kg solumedrol) at anesthetic induction , * mastoidectomy + posterieur tympanostomy , * insertion through round window, * stop at the first resistance point |
Timeline
- Start date
- 2016-03-30
- Primary completion
- 2018-10-02
- Completion
- 2018-10-02
- First posted
- 2016-11-17
- Last updated
- 2021-10-14
Locations
8 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02966379. Inclusion in this directory is not an endorsement.