N/A
Completed N=36
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
Severe to Profound Hearing Loss · in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Source: ClinicalTrials.gov NCT01616576 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. — 0.2; 88.3; 88.5; 2.8 Percent Correct
Summary
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. |
0.2; 88.3; 88.5; 2.8; 61.2; 64.0 | — |
| PRIMARY Device-related Adverse Events |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
- 18 years of age or older at time of implant
- Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
- At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
- English language proficiency
- Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
- Willingness and ability to participate in all scheduled procedures outlined in the protocol
Exclusion Criteria
- Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
Data sourced from ClinicalTrials.gov (NCT01616576). 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. Informational only — not medical advice.