NCT01616576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

July 22, 2020

Status Verified

August 1, 2014

Enrollment Period

4 months

First QC Date

June 1, 2012

Results QC Date

February 26, 2014

Last Update Submit

July 8, 2020

Conditions

Severe to Profound Hearing Lossin Adult Users of Advanced Bionics HiResolution™ Bionic Ear System

Keywords

cochlear implantadultsHiResolution™Fidelity 120™listening benefitsnoisecochlear implant benefit

Outcome Measures

Primary Outcomes (2)

  • 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

  • Device-related Adverse Events

    Device-related adverse events will be assessed to determine whether they impact current device safety performance.

    2 weeks

Study Arms (2)

Control first, then Experimental (Group A)

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.

Device: Control first, then Experimental

Experimental first, then Control (Group B)

EXPERIMENTAL

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.

Device: Experimental first, then Control

Interventions

Control first, then ExperimentalDEVICE

Control condition is currently marketed sound processing strategy.

Control first, then Experimental (Group A)
Experimental first, then ControlDEVICE

Experimental condition is newly modified sound processing strategy.

Experimental first, then Control (Group B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

House Ear Clinic

Los Angeles, California, 90057, United States

Location

Tampa Bay Hearing and Balance

Tampa, Florida, 33606, United States

Location

Carle Clinic Association

Urbana, Illinois, 61801, United States

Location

Midwest Ear Institute (MEI)

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

Title
Cedric Navarro, Vice President of Regulatory/Clinical Affairs and Quality
Organization
Advanced Bionics, LLC
Clinical.Research@advancedbionics.com
(661) 362-1963

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 12, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 22, 2020

Results First Posted

August 15, 2014

Record last verified: 2014-08

Locations

US(5)