N/A
N=19
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Hearing Loss · Ear Diseases · Hearing Disorders · Otolaryngological Disease
Bottom Line
View on ClinicalTrials.gov: NCT05034731 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Speech Performance in Quiet After Chronic Use (EO Only) — 89.28; 91.94 percentage of correctly recognized words — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Fitting (Device); In-Office Fitting (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Advanced Bionics
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Performance in Quiet After Chronic Use (EO Only) |
89.28; 91.94 | <0.0001 sig |
| PRIMARY Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) |
89.28; 88.46; 89.04; 91.94; 88.72; 90.99 | <0.0001 sig |
Summary
This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
Eligibility Criteria
Inclusion Criteria All Subjects
- Ability to provide Informed Consent/Assent
- 13 years of age or older
- Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D)
- Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor
- At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1)
- Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16)
- English language proficiency as determined by the Investigator
- Willingness to use a BTE sound processor for the duration of the study
Inclusion Criteria Specific to Aidable Residual Hearing Group
- 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 for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
- Willingness to use an in-canal acoustic earhook for the duration of the study
Exclusion Criteria
- Clinical presentation indicative of potential implanted device malfunction
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
- Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
Data sourced from ClinicalTrials.gov (NCT05034731). 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.