CP1110 Sound Processor Feasibility

Cochlear21 enrolled

Overview

The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..

The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Processor when compared to the CP1000 Sound Processor. To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adult Cochlear Implant Recipients

Interventions

CP1110DEVICE

Sound Processor

CP1000DEVICE

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 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or 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 Via Sentence Scores in Spatially Separated Adaptive Noise

Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome.

Time frame: One day

Secondary Outcomes

Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet

Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. Secondary Endpoint 1: CNC Words correct in quiet (50 dB) with both CP1000 and CP1110 sound processors using Signal-to-Noise Ratio - Noise Reduction (SNR-NR) turned on.

Time frame: One day

Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet

Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score using both CP1110 and CP1000 sound processors Signal-to-Noise Ratio - Noise Reduction (SNR-NR) off with expander on.

Time frame: One day

Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet

Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score of CP1110 sound processor ForwardFocus ON (Moderate) vs CP1000 sound processor Signal-to-Noise Ration-Noise Reduction) On.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.