N/A
Completed N=22
Clinical Evaluation of a Cochlear Implant Sound Processor
Hearing Loss · Ear Diseases · Hearing Disorders · Otorhinolaryngologic Diseases
Source: ClinicalTrials.gov NCT04237207 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Speech Recognition in Quiet — 88.31; 89.39; 87.30; 88.09 percentage of correct words — p=0.0010
Summary
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Recognition in Quiet |
88.31; 89.39; 87.30; 88.09 | 0.0010 sig |
| SECONDARY Speech Recognition in Noise |
52.95; 66.04; 76.37; 84.98 | 0.0010 sig |
| SECONDARY Increased Speech Recognition in Noise |
42.93; 51.37; 76.37; 84.98 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04237207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.