An interventional study of cochlear implantation in Cochlear Implant, sponsored by Oticon Medical. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by Oticon Medical · Not applicable, Interventional, and Treatment
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.
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).
Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
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
Time frame: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation
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).
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
Time frame: 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).
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
Time frame: 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.
Time frame: 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
Time frame: 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.
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")
Time frame: single evaluation at implantation only
Plan to share: No
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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