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OpenTrials
Completed

NCT Number: NCT01616576

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

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

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

House Ear Clinic, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control first, then Experimental

Device

Control condition is currently marketed sound processing strategy.

Experimental first, then Control

Device

Experimental condition is newly modified sound processing strategy.

Primary outcomes

  1. Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.

    Time frame: 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.

  2. Device-related Adverse Events

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 12, 2012
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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