Cochlear Response Telemetry and Hearing Preservation (CREST)

Cochlear

Status: Terminated

Conditions: Hearing Impairment, Sensorineural

Treatments: Device: Cochlear implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03134989

CLTD5667

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Cochlear implant recipients

Other group

Description:

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

Treatment:

Device: Cochlear implant