CLEAR Clinical Study

Clinical Evaluation of the SpatialNR Noise Reduction Algorithm

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03126825

Enrollment

Registered

2017-04-24

Start date

2017-05-01

Completion date

2017-09-01

Last updated

2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Brief summary

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

Interventions

DEVICECP910/CP920 with noise reduction on

This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.

DEVICECP910/CP920

The approved CP910 or CP920 Sound Processor.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
CNC words	3 months	CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
SRT sentences	3 months	SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026