Clinical trial NCT04237207: Clinical Evaluation of a Cochlear Implant Sound Processor
Official title: Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

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

Primary outcomes:
measure: Speech Recognition in Quiet
timeFrame: 1 Day
Secondary outcomes:
measure: Speech Recognition in Noise
timeFrame: 1 Day
measure: Increased Speech Recognition in Noise
timeFrame: 1 Day
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Tampa
country: United States
facility: Tampa Bay Hearing and Balance Center
state: Florida
city: Kansas City
country: United States
facility: Midwest Ear Institute/St. Luke's Health System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Ear, Nose & Throat Clinic
state: Texas
Study officials:
References: