Clinical Evaluation of a Cochlear Implant Sound Processor

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

• Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software (Device): Control cochlear implant sound processor
• 301-M062 sound processor & software (Device): New cochlear implant sound processor

Primary outcomes

• Speech Recognition in Quiet [1 Day]: The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

Secondary outcomes

• Speech Recognition in Noise [1 Day]: Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
• Increased Speech Recognition in Noise [1 Day]: Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

Sex: All, ages: 18 Years to any

General Inclusion Criteria:

* Ability to provide Informed Consent
* 18 years of age or older
* Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality
* Minimum of 6 months of CI experience
* Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month
* Presently using a current steering strategy
* At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor
* English language proficiency as determined by the investigator
* Willingness to use a BTE processor for the duration of the study

ARH Arm Inclusion Criteria

* Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
* Willingness to use an in-canal acoustic earhook for the duration of the study

EO Arm Inclusion Criteria

• Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear

Exclusion Criteria:

* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
* Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator

Participant flow

Outcome results

• Speech Recognition in Quiet (Primary), Mean, percentage of correct words: EO Cohort 88.31 +/- 5.817; ARH Cohort 89.39 +/- 10.535 (p 0.0010)
• Speech Recognition in Noise (Secondary), Mean, percentage of correct word responses: EO Cohort 52.95 +/- 31.163; ARH Cohort 66.04 +/- 25.939 (p 0.0010)
• Increased Speech Recognition in Noise (Secondary), Mean, percentage of correct words recognized: EO Cohort 42.93 +/- 30.801; ARH Cohort 51.37 +/- 28.604 (p <0.0001)

Adverse events

Time frame: AEs were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit. The total period is up to 5 weeks.

Other adverse events by term

Limitations and caveats: Due to clinic closures related to the COVID-19 pandemic, total enrollment in the EO Cohort was 10 subjects instead of 12.

• Study Protocol and Statistical Analysis Plan (PDF, 2019-11-13)