CompletedNot Applicable

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

United States36 participantsStarted 2012-05

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 weeks

Device-related Adverse Events

Timeframe: 2 weeks

Trial details

NCT IDNCT01616576

SponsorAdvanced Bionics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

Results submitted2014-02-26

View on ClinicalTrials.gov More Severe to Profound Hearing Loss trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.