Clinical Evaluation of a Cochlear Implant System

Cochlear

Status: Completed

Conditions: Sensorineural Hearing Loss

Treatments: Device: Nucleus 7 Cochlear Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03467399

CLTD5620

Details and patient eligibility

About

The primary objective of this study is to assess the usability of a Cochlear implant system.

Full description

Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Enrollment: 46 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Fluent speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

Exclusion criteria

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Cochlear implant users

Experimental group

Description:

This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.

Treatment:

Device: Nucleus 7 Cochlear Implant System