N/A
N=24
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Hearing Loss · Ear Diseases · Hearing Disorders · Otorhinolaryngologic Diseases · Asymmetrical Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT02811549 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only) — 2.13; 61.14 percentage of recognized words
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HiResolution Bionic Cochlear Implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanced Bionics
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only) |
2.13; 61.14 | — |
| PRIMARY Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only) |
17.14; 17.14; 17.86; 20.00; 23.21; 25.71 | — |
| PRIMARY Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front |
87.39; 91.20 | — |
| PRIMARY Change in Lateralization Ability Testing (Bilateral Listening Condition) |
72; 89.10 | — |
| PRIMARY Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear |
92.15; 93.01 | — |
| PRIMARY Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear. |
82.24; 89.10 | — |
Summary
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
Eligibility Criteria
Inclusion Criteria
General Requirements:
- Ability to provide Informed Consent
- 18 years of age or older
- English language proficiency
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study
Ear to be Implanted:
- Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
- CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
- Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and ≤10 years in the ear to be implanted only
Contralateral (non-implanted) ear:
- Up to a moderate sensorineural hearing loss ( 30% (tested in subject's everyday listening condition for that ear)
Exclusion Criteria
- Previous experience with a cochlear implant
- Cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted
- Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
- Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
- Active middle-ear disease/infection in the ear to be implanted
- Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures 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 (NCT02811549). 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.