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

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ClinicalTrials.gov Identifier: NCT02966379
Recruitment Status : Unknown
Verified August 2018 by Oticon Medical.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

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.


Condition or disease Intervention/treatment Phase
Cochlear Implant Device: cochlear implantation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
Actual Study Start Date : March 30, 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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




Primary Outcome Measures :
  1. Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation [ Time Frame: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation ]
    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


Secondary Outcome Measures :
  1. 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). [ Time Frame: 3, 6 and 12 months post activation ]
    Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" when presented in quiet with the three modes of stimulation (AS, ES and EAS). Speech understanding is evaluated at 3, 6 and 12 months post activation

  2. 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). [ Time Frame: 3, 6 and 12 months post activation ]
    Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" when presented in cocktail party noise at 0 and +10 dB Speech to Noise Ratio (SNR) with the three modes of stimulation (AS, ES and EAS). Speech understanding is evaluated at 3, 6 and 12 months post activation

  3. Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations. [ Time Frame: 2 weeks pre op, 3, 6 and 12 months post-activation ]
  4. Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds [ Time Frame: 6 and 12 months post activation ]
  5. 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. [ Time Frame: single evaluation at implantation only ]
    Surgery questionnaire evaluating the surgical technique (multiple choice questions), the presence of problems during surgery (multiple choice questions), the difficulty of insertion of the implant (scales from 0 - impossible to 5 - very easy; or 0 -very easy to 5 - impossible on inverted questions), the tools used for the insertion (multiple choice questions), the duration of insertion (secondes or minutes),the number of electrode inserted, the number of attempts to insert, and surgeon satisfaction (multiple choice questions between "easy", "medium" and "difficult")



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966379


Locations
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France
CHU Bordeaux Pellegrin
Bordeaux, France
CHRU Lille Hôpital Roger Salengro
Lille, France
CHU Lyon Hôpital Edouard Herriot
Lyon, France
APHM - Hôpital Nord Marseille
Marseille, France
CHRU de Nancy hôpital Central
Nancy, France
IUFC - CHU Nice
Nice, France
APHP Pitie salpetriere
Paris, France
CHU Rennes Pontchaillou
Rennes, France
Sponsors and Collaborators
Oticon Medical
Investigators
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Study Director: Dan Gnansia, Dr Oticon Medical
Principal Investigator: Yann NGUYEN, Dr APHP Pitie salpetriere
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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT02966379    
Other Study ID Numbers: PIC_06
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Oticon Medical:
Electroacoustic stimulation