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

Advanced Bionics

Status: Completed

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

Treatments: Device: Control first, then Experimental; Device: Experimental first, then Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01616576

CR0611

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Control first, then Experimental (Group A)

Experimental group

Description:

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.

Treatment:

Device: Control first, then Experimental

Experimental first, then Control (Group B)

Experimental group

Description:

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.

Treatment:

Device: Experimental first, then Control