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

NCT ID: NCT02966379

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-30

Study Completion Date

2018-10-02

Brief Summary

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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

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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

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Cochlear Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cochlear implantation

Cochlear implantation with EVO electrode lead. This electrode lead has been specially designed for atraumatic surgery, in order to preserve the residual hearing of the patients included in the study. All patients are implanted with the same electrode lead.

Group Type EXPERIMENTAL

cochlear implantation

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Agreement to participate
* Above 18 years old
* Candidate for cochlear implantation
* Residual hearing in low frequencies (auditory thresholds better than or equal to 70 dB up to 500 Hz
* Native or fluent French speaker

Exclusion Criteria

* No affiliation to social security
* No agreement
* Vulnerable patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Gnansia, Dr

Role: STUDY_DIRECTOR

Oticon Medical

Yann NGUYEN, Dr

Role: PRINCIPAL_INVESTIGATOR

APHP Pitie salpetriere

Locations

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CHU Bordeaux Pellegrin

Bordeaux, , France

Site Status

CHRU Lille Hôpital Roger Salengro

Lille, , France

Site Status

CHU Lyon Hôpital Edouard Herriot

Lyon, , France

Site Status

APHM - Hôpital Nord Marseille

Marseille, , France

Site Status

CHRU de Nancy hôpital Central

Nancy, , France

Site Status

IUFC - CHU Nice

Nice, , France

Site Status

APHP Pitie salpetriere

Paris, , France

Site Status

CHU Rennes Pontchaillou

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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PIC_06

Identifier Type: -

Identifier Source: org_study_id