Clinical trial NCT02966379: Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
Official title: Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implant
Keywords: Electroacoustic stimulation
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation
timeFrame: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation
Secondary outcomes:
measure: 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).
timeFrame: 3, 6 and 12 months post activation
measure: 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).
timeFrame: 3, 6 and 12 months post activation
measure: Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations.
timeFrame: 2 weeks pre op, 3, 6 and 12 months post-activation
measure: Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds
timeFrame: 6 and 12 months post activation
measure: 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.
timeFrame: single evaluation at implantation only
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux Pellegrin
city: Lille
country: France
facility: CHRU Lille Hôpital Roger Salengro
city: Lyon
country: France
facility: CHU Lyon Hôpital Edouard Herriot
city: Marseille
country: France
facility: APHM - Hôpital Nord Marseille
city: Nancy
country: France
facility: CHRU de Nancy hôpital Central
city: Nice
country: France
facility: IUFC - CHU Nice
city: Paris
country: France
facility: APHP Pitie salpetriere
city: Rennes
country: France
facility: CHU Rennes Pontchaillou
Study officials:
affiliation: Oticon Medical
name: Dan Gnansia, Dr
role: STUDY_DIRECTOR
affiliation: APHP Pitie salpetriere
name: Yann NGUYEN, Dr
role: PRINCIPAL_INVESTIGATOR
References: