Cochlear Response Telemetry and Hearing Preservation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2020-06-18

Brief Summary

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The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. The measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.

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Detailed Description

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Conditions

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Hearing Impairment, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cochlear implant recipients

Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.

Group Type OTHER

Cochlear implant

Intervention Type DEVICE

Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery

Interventions

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Cochlear implant

Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
* 18 years of age or older at the time of enrolment
* Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL
* Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria

* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy
* Active middle-ear infection
* Additional handicaps that would prevent participation in evaluations
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No