N/A N=102 Treatment

Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Sensorineural Hearing Loss, Bilateral · Cochlear Implant

Bottom Line

View on ClinicalTrials.gov: NCT03304106 ↗

Enrolled (actual)

102

Serious AEs

6.9%

Results posted

Oct 2020

Primary outcome: Primary: Change in Monosyllabic Word Recognition Scores (CNC) in Quiet — 13.9; 60.1; 60.2; 59.1 percentage of correct words

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Commercially available cochlear implant and AI system (Device)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Cochlear
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Monosyllabic Word Recognition Scores (CNC) in Quiet	13.9; 60.1; 60.2; 59.1	—

Summary

Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

Eligibility Criteria

Inclusion Criteria

Newly implanted and existing recipient Groups (Groups 1 and 2):

Age 12 and older
Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
Group 2: 3 months or greater combined experience with commercially available sound processors
Fluent spoken English skills

Exclusion Criteria

Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
Unwillingness or inability of the subject to comply with all investigational requirements
Use of an acoustic component in the implanted ear
Less than 18 active electrodes
Hybrid L Cochlear Implant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03304106). 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.