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

NCT02966379 | Completed

• 1 other identifier: PIC_06
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Electroacoustic stimulation

Outcome Measures

Primary Outcomes (1)

• Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation

  Change from pre-implantation pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz at 1 month post implantation with the EVO electrode lead and at 1, 3, 6 and 12 months post-activation

  2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation

Secondary Outcomes (5)

• Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in quiet with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).

  3, 6 and 12 months post activation

• Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in cocktail party noise with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).

  3, 6 and 12 months post activation

• Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations.

  2 weeks pre op, 3, 6 and 12 months post-activation

• Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds

  6 and 12 months post activation

• Surgery questionnaire evaluating the surgical technique, the presence of problems during surgery, the quality of insertion and surgeon satisfaction with multiple choice questions, close questions and scales from 0 to 10.

  single evaluation at implantation only

Study Arms (1)

Cochlear implantation

EXPERIMENTAL

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.

Device: cochlear implantation

Interventions

cochlear implantation 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

Cochlear implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No affiliation to social security
• No agreement
• Vulnerable patient

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (8)

CHU Bordeaux Pellegrin

Bordeaux, France

Location

CHRU Lille Hôpital Roger Salengro

Lille, France

Location

CHU Lyon Hôpital Edouard Herriot

Lyon, France

Location

APHM - Hôpital Nord Marseille

Marseille, France

Location

CHRU de Nancy hôpital Central

Nancy, France

Location

IUFC - CHU Nice

Nice, France

Location

APHP Pitie salpetriere

Paris, France

Location

CHU Rennes Pontchaillou

Rennes, France

Location

MeSH Terms

Interventions

Cochlear Implantation

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Dan Gnansia, Dr

  Oticon Medical

  STUDY DIRECTOR

• Yann NGUYEN, Dr

  APHP Pitie salpetriere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 17, 2016
• Study Start: March 30, 2016
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)