Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear

Not Applicable

Completed

• Conditions: in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System; Severe to Profound Hearing Loss
• Interventions: Device: Control first, then Experimental; Device: Experimental first, then Control

• Registration Number: NCT01616576
• Lead Sponsor: Advanced Bionics

Brief Summary

The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Disposition First Submitted: 2013-01-27
• Disposition First Submitted QC: 2013-01-27
• Disposition First Posted: 2013-01-29
• Results First Submitted: 2014-02-26
• Results First Submitted QC: 2014-07-25
• Status Verified: 2014-08
• Results First Posted: 2014-08-15
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control first, then Experimental (Group A)	Control first, then Experimental	Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
Experimental first, then Control (Group B)	Experimental first, then Control	Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.

Primary Outcome Measures

Name	Time	Method
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.	2 weeks	Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Device-related Adverse Events	2 weeks	Device-related adverse events will be assessed to determine whether they impact current device safety performance.

Trial Locations

Locations (5)

Carle Clinic Association; 🇺🇸 Urbana, Illinois, United States

House Ear Clinic; 🇺🇸 Los Angeles, California, United States

Tampa Bay Hearing and Balance; 🇺🇸 Tampa, Florida, United States

Midwest Ear Institute (MEI); 🇺🇸 Kansas City, Missouri, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States