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

NCT ID: NCT01616576

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-09-30

Brief Summary

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

Conditions

Severe to Profound Hearing Loss; in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control first, then Experimental (Group A)

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.

Group Type: EXPERIMENTAL

Control first, then Experimental

Intervention Type: DEVICE

Control condition is currently marketed sound processing strategy.

Experimental first, then Control (Group B)

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.

Group Type: EXPERIMENTAL

Experimental first, then Control

Intervention Type: DEVICE

Experimental condition is newly modified sound processing strategy.

Interventions

Control first, then Experimental

Control condition is currently marketed sound processing strategy.

Intervention Type: DEVICE

Experimental first, then Control

Experimental condition is newly modified sound processing strategy.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Bionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

House Ear Clinic

Los Angeles, California, United States

Tampa Bay Hearing and Balance

Tampa, Florida, United States

Carle Clinic Association

Urbana, Illinois, United States

Midwest Ear Institute (MEI)

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

CR0611

Identifier Type: -

Identifier Source: org_study_id