Cochlear Response Telemetry and Hearing Preservation

NCT03134989 | Terminated Results

• 1 other identifier: CLTD5667
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Impairment, Sensorineural

Keywords

cochlear implantation, electrocochleography

Outcome Measures

Primary Outcomes (1)

• Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.

  Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 4 to 6 weeks following surgery and compared with average LF hearing thresholds measured relative to the pre-operative baseline measured within 90 days of CI surgery. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response?

  Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery

Secondary Outcomes (2)

• Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.

  Baseline (pre-operative) compared to 3 months post cochlear implant activation

• Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected).

  Intraoperative

Study Arms (1)

Cochlear implant recipients

OTHER

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

Device: Cochlear implant

Interventions

Cochlear implant DEVICE

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

Cochlear implant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: Ruth English
• Organization: Cochlear

REnglish@cochlear.com

0386633105

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 1, 2017
• Study Start: December 22, 2017
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)