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

Cochlear Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966379
• Other study ID #: PIC_06
• Status: Completed
• Phase: N/A
• Start date: March 30, 2016
• Est. completion date: October 2, 2018

Study information

• Verified date: October 2021
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	3, 6 and 12 months post activation
Secondary	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	3, 6 and 12 months post activation
Secondary	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
Secondary	Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds		6 and 12 months post activation
Secondary	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")	single evaluation at implantation only