Phase 4
N=32
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT00205881 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. — 4.0; 69.0 percent of words correct
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HiRes 90K Bionic Ear System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanced Bionics
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. |
4.0; 69.0 | — |
| SECONDARY HINT Sentences in Noise |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00205881). 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.