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

Severe to Profound Hearing Loss Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616576
• Other study ID #: CR0611
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: August 2014
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Control first, then Experimental
Control condition is currently marketed sound processing strategy.
• Experimental first, then Control
Experimental condition is newly modified sound processing strategy.

Locations

Country	Name	City	State
United States	Midwest Ear Institute (MEI)	Kansas City	Missouri
United States	House Ear Clinic	Los Angeles	California
United States	Washington University	Saint Louis	Missouri
United States	Tampa Bay Hearing and Balance	Tampa	Florida
United States	Carle Clinic Association	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.	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.	2 weeks
Primary	Device-related Adverse Events	Device-related adverse events will be assessed to determine whether they impact current device safety performance.	2 weeks