Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.

Cochlear20 enrolled

Overview

The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adult Cochlear Implant Recipients

Interventions

CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF)DEVICE

Sound Processor

Nucleus 7 Sound Processor (model: CP1000) systemDEVICE

Sound Processor

CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)DEVICE

Sound Processor

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 years or older. 2. Post lingually deafened. 3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422). 4. At least 6 months experience with a cochlear implant. 5. At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor 6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test 7. Willingness to participate in and to comply with all requirements of the protocol. 8. Fluent speaker in English as determined by the investigator 9. Willing and able to provide written informed consent Exclusion Criteria: 1. Additional disabilities that would prevent participation in evaluations. 2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures. 3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 6. Currently participating, or participated in another interventional clinical study/trial in the past 30 days or if less than 30 days, the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

Locations (1)

Cochlear Sydney

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)

Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.

Time frame: 6 months

Secondary Outcomes

Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)

Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus On (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0N3 Babble.

Time frame: 6 months

Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor

Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and Nucleus 7 Sound Processor.

Time frame: 6 months

Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor

Paired difference in Global Speech, Spatial and Qualities of Hearing Scale (SSQ12) scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses. SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome.

Time frame: Baseline (Nucleus 7) and Visit 2 (6 months, CP1110)

Data from ClinicalTrials.gov

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