Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Advanced Bionics
- Enrollment
- 32
- Locations
- 17
- Primary Endpoint
- Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Study Overview
Brief Summary
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •No previous implant experience.
- •Age 18 years or older.
- •Postlingual onset of hearing loss.
- •Sensorineural hearing loss of a severe or greater degree in both ears.
- •Normal/patent cochlear anatomy in each ear.
- •English language proficiency.
- •Willingness and ability to participate in all scheduled procedures.
Exclusion Criteria
- •No exclusion criteria specified, except for the opposite of inclusion criteria listed above.
Outcomes
Primary Outcomes
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Time Frame: 8 months of bilateral cochlear implant use
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
Secondary Outcomes
- HINT Sentences in Noise(8 months of bilateral cochlear implant use)