TerminatedNot Applicable

Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

Stopped: Thirty-five subjects wore the EAS processor for as long as 84 months without significant safety issues. Sufficient data gained to support EAS technology development for safe use in subjects with residual low-frequency acoustic hearing sensitivity.

United States67 participantsStarted 2014-10-21

Plain-language summary

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

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: Newly Implanted Group: * Ability to provide informed consent * No previous cochlear implant experience in either ear * 18 years of age or older * Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the ear to be implanted * Aided CNC word recognition score up to 50% in ear to be implanted * Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear * Aided CNC word recognition score up to 80% in the contralateral ear * English language proficiency * Willingness to use an ear-level sound processor postoperatively for the duration of the study trial * Willingness to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: Newly Implanted Group: * Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or more in range of 500-1000 Hz in the ear to be implanted * Congenital hearing loss (for purpose of this study, onset prior to age 2 years\*). \*Based on critical period for speech and language development * Duration greater th…

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

Unaided Pure-tone Average (PTA) Hearing Threshold Measurements

Timeframe: Twelve months post device activation

Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet

Timeframe: Up to 12 months post device activation

Speech Perception Testing (AzBio) in Noise.

Timeframe: up to 12 months post device activation

Trial details

NCT IDNCT02189798

SponsorAdvanced Bionics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-29

Results submitted2025-02-12

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