CLEAR Clinical Study

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: CP910/CP920 with noise reduction on; Device: CP910/CP920

Study type: Interventional

Funder types: Industry

Identifiers

NCT03126825

CLTD5606

Details and patient eligibility

About

Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.

Enrollment: 48 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
2. Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
3. At least three months CI experience in ear to be assessed
4. At least three months experience with the CP810,CP920 or CP910 sound processor
5. Fluent speaker in the local language used to assess clinical performance
6. Open-set speech perception ability
7. Use of or eligibility for hybrid acoustic component (hybrid population only)

Exclusion criteria

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
2. Unwillingness or inability of the candidate to comply with all investigational requirements
3. Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Conventional CI

Other group

Description:

The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.

Treatment:

Device: CP910/CP920 with noise reduction on

Device: CP910/CP920

Hybrid CI

Other group

Description:

The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.

Treatment:

Device: CP910/CP920 with noise reduction on

Device: CP910/CP920