Hearing LossNCT02189798

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

A study testing HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode and EAS sound processor in people with Hearing Loss and Partial Deafness, run by Advanced Bionics at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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™… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss, Partial Deafness, Hearing Disorders
What is being tested?: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode and EAS sound processor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 11 sitesUnited States
Study dates: 21 Oct 2014to 29 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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 than 30 years of severe-to-profound high-frequency hearing loss
Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted
Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear

Show all 20Show fewer

Active middle-ear disease/infection in the ear to be implanted
Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups
Ability to provide informed consent
18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor (i.e. Naída family device)
Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz
English Language Proficiency
Willingness to participate in all scheduled procedures outlined in the study protocol
EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups
Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode
Exclusive use of a body worn external sound processor
Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
Postoperative unaided low frequency audiometric hearing thresholds in the treated ear exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Austin Ear, Nose & Throat Clinic
Austin, Texas, 78731
University of Missouri
Columbia, Missouri, 65201
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, 37232
New York University Langone Medical Center
New York, New York, 10016
Oklahoma Ear Institute
Oklahoma City, Oklahoma, 73104
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
Midwest Ear Institute/St. Luke's Health System
St Louis, Missouri, 64111
Tampa Bay Hearing and Balance Center
Tampa, Florida, 33606
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Conditions: Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases
Being tested: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, EAS sound processor
Keywords: Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, Electrical Stimulation, Electro-Acoustic Stimulation (EAS)
Medical subject headings: Hearing Loss, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrodeDevice
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
EAS sound processorDevice
Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

Study groups in NCT02189798
Study group	Role	What they receive
Newly Implanted Group	Experimental	HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. Receives: Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode; Device: EAS sound processor
Existing Implanted Group	Experimental	Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. Receives: Device: EAS sound processor
EAS Extended Use Arm	Experimental	Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group. Receives: Device: EAS sound processor

What is being measured

The primary outcome is the main question the study is designed to answer.

Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
Measured: Twelve months post device activation
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Measured: Up to 12 months post device activation
Speech Perception Testing (AzBio) in Noise.
Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Measured: up to 12 months post device activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 201429 Mar 2022

First posted15 Jul 2014 (estimated)
Study start21 Oct 2014
Primary completion29 Mar 2022
Study completion29 Mar 2022

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189798
Sponsor's protocol ID: CR0114
Status last verified: May 2025
First submitted: 10 Jul 2014
Last updated: 8 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02189798
Acronym / sponsor ID: CR0114
Conditions: Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases
Keywords: Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, Electrical Stimulation
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 67 participants (actual)
Lead sponsor: Advanced BionicsIndustry (pharma, biotech, devices)
Study start: 21 Oct 2014 (actual)
Primary completion: 29 Mar 2022 (actual)
Study completion: 29 Mar 2022 (actual)
First posted: 15 Jul 2014 (estimated)
Results: Posted 8 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.

Arm	Type	Receives
Newly Implanted Group	Experimental	Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode, Device: EAS sound processorHiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor.
Existing Implanted Group	Experimental	Device: EAS sound processorAdults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
EAS Extended Use Arm	Experimental	Device: EAS sound processorAdults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (20 listed)

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 than 30 years of severe-to-profound high-frequency hearing loss
Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted
Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrodeHiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).	Device	Newly Implanted Group
EAS sound processorPatients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.	Device	EAS Extended Use Arm, Existing Implanted Group, Newly Implanted Group

Primary outcome

Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
Time frame: Twelve months post device activation
Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet
Time frame: Up to 12 months post device activation
Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.
Speech Perception Testing (AzBio) in Noise.
Time frame: up to 12 months post device activation
Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.

Results and safety

Results posted to the registry on 8 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Newly Implanted Group	49	22
Existing Implanted Group	18	13

Primary outcome: Unaided Pure-tone Average (PTA) Hearing Threshold Measurements

Time frame: Twelve months post device activation. Mean (Standard Deviation). Unit: decibles

Measure	Newly Implanted Subjects n = 15	Existing Implanted n = 10
Baseline PTA	46.7 (8.7)	72.0 (19.5)
3 Month PTA	69.4 (12.1)	71.6 (20.5)
6 Month PTA	67.5 (12.2)	72.6 (18.9)
12 Month PTA	71.6 (15.6)	74.5 (17.1)

Population analysed: Analysis includes only subjects who completed up to month 3 using the EAS processor.

Primary outcome: Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet

Time frame: Up to 12 months post device activation. Mean (Standard Deviation). Unit: Percent words correct

Measure	Newly Enrolled n = 15	Existing Implanted n = 10
Baseline	19.3 (13.5)	61.5 (19.5)
Month 1 Post Device /EAS Activation	31.3 (25.8)	67.1 (17.8)
Month 3 Post Device /EAS Activation	50.4 (28.0)	70.5 (15.9)
Month 6 Post Device /EAS Activation	50.5 (25.6)	72.7 (18.3)
Month 12 Post Device /EAS Activation	51.1 (25.0)	73.3 (19.2)

Population analysed: Analysis includes only subjects who completed up to month 12 using the EAS processor.

Primary outcome: Speech Perception Testing (AzBio) in Noise.

Time frame: up to 12 months post device activation. Mean (Standard Deviation). Unit: Percent words correct

Measure	Newly Enrolled n = 15	Existing Implanted n = 15
Baseline	11.9 (8.5)	46.2 (22.6)
1 Month Post Device/ EAS Activation	19 (19.7)	55.0 (27.1)
3 Month Post Device/ EAS Activation	42.1 (28.3)	57.7 (25.8)
6 Month Post Device/ EAS Activation	44.4 (28)	62.6 (27.1)
12 Month Post Device/ EAS Activation	46.2 (26.3)	64.1 (23.2)

Population analysed: Analysis includes only subjects who completed the main phase study using the EAS processor.

Adverse events

Time frame: Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Newly Implanted Group	16 of 49 (32.7%)	24 of 49 (49%)	1 of 49
Existing Implanted Group	0 of 18 (0%)	9 of 18 (50%)	0 of 18
Extended Use Phase - Newly Implanted Group	1 of 15 (6.7%)	4 of 15 (26.7%)	0 of 15
Extended Use Phase - Existing Implanted Group	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unaided Pure-tone Average (PTA) Hearing Threshold Measurements (time frame: Twelve months post device activation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.