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Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

NCT02966379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

  • Cochlear Implant

Interventions

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

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Dan Gnansia, Dr · Oticon Medical

  • Yann NGUYEN, Dr · APHP Pitie salpetriere

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-30
Primary Completion
2018-10-02
Completion
2018-10-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02966379 on ClinicalTrials.gov