Hearing LossNCT02811549

Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

A study testing HiResolution Bionic Cochlear Implant in people with Hearing Loss and Ear Diseases, run by Advanced Bionics at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss, Ear Diseases, Hearing Disorders
What is being tested?: HiResolution Bionic Cochlear Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 7 Nov 2016to 25 Mar 2020
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

General Requirements:
Ability to provide Informed Consent
18 years of age or older
English language proficiency
Willingness to participate in all scheduled procedures outlined in the study investigational plan
Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

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Ear to be Implanted:
Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and ≤10 years in the ear to be implanted only
Contralateral (non-implanted) ear:
Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
CNC word recognition score >30% (tested in subject's everyday listening condition for that ear)

Who cannot join

Previous experience with a cochlear implant
Cochlear malformation or obstruction (i.e. ossification) 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
Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The Silverstein Institute
Sarasota, Florida, 34239
Virginia Mason Medical Center
Seattle, Washington, 98101

Other trials in United States

About this study

Conditions: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Asymmetrical Hearing Loss, Single-Sided Deafness
Being tested: HiResolution Bionic Cochlear Implant
Keywords: Cochlear Implant, HiRes™ 90K Advantage Implant, HiFocus™ Mid-Scala electrode, HiFocus™ 1J electrode, HiFocus Helix™ electrode, Cochlear Implantation, Listening Benefits, Adults, Cochlear Implant Benefit, Electrical Stimulation, HiRes™ Ultra Implant with HiFocus™ Mid-Scala electrode
Medical subject headings: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases

What participants receive

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

HiResolution Bionic Cochlear ImplantDevice
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.

Study groups in NCT02811549
Study group	Role	What they receive
HiResolution Bionic Cochlear Implant	Experimental	HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss). Receives: Device: HiResolution Bionic Cochlear Implant

What is being measured

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

Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Measured: Baseline and Twelve months
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.
- Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Measured: Baseline and Twelve months
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Measured: Baseline and Twelve months
Change in Lateralization Ability Testing (Bilateral Listening Condition)
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Measured: Baseline and Twelve months
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Measured: Baseline to Twelve Months
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Measured: Baseline to Twelve Months

Timeline

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

7 Nov 201625 Mar 2020

First posted23 Jun 2016 (estimated)
Study start7 Nov 2016
Primary completion25 Mar 2020
Study completion25 Mar 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02811549
Sponsor's protocol ID: CR0314
Status last verified: Jul 2023
First submitted: 7 Jun 2016
Last updated: 21 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Enrolling by invitation
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Hearing Loss
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
ClinicalTrials.gov ID: NCT02811549
Acronym / sponsor ID: CR0314
Conditions: Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Asymmetrical Hearing Loss, Single-Sided Deafness
Keywords: Cochlear Implant, HiRes™ 90K Advantage Implant, HiFocus™ Mid-Scala electrode, HiFocus™ 1J electrode, HiFocus Helix™ electrode, Cochlear Implantation, Listening Benefits, Adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Advanced BionicsIndustry (pharma, biotech, devices)
Study start: 7 Nov 2016 (actual)
Primary completion: 25 Mar 2020 (actual)
Study completion: 25 Mar 2020 (actual)
First posted: 23 Jun 2016 (estimated)
Results: Posted 21 Aug 2023

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HiResolution Bionic Cochlear Implant	Experimental	Device: HiResolution Bionic Cochlear ImplantHiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

Who may qualify

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

Key inclusion criteria (13 listed)

Ability to provide Informed Consent
18 years of age or older
English language proficiency
Willingness to participate in all scheduled procedures outlined in the study investigational plan
Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

Key exclusion criteria (7 listed)

Previous experience with a cochlear implant
Cochlear malformation or obstruction (i.e. ossification) 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
Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
Active middle-ear disease/infection in the ear to be implanted

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
HiResolution Bionic Cochlear ImplantHiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.	Device	HiResolution Bionic Cochlear Implant

Primary outcome

Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
Time frame: Baseline and Twelve months
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Time frame: Baseline and Twelve months
Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary. • Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
Time frame: Baseline and Twelve months
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Change in Lateralization Ability Testing (Bilateral Listening Condition)
Time frame: Baseline and Twelve months
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
Time frame: Baseline to Twelve Months
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
Time frame: Baseline to Twelve Months
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

Results and safety

Results posted to the registry on 21 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HiResolution Bionic Cochlear Implant	24	14

Primary outcome: Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)

Time frame: Baseline and Twelve months. Mean (Standard Deviation). Unit: percentage of recognized words

Measure	HiResolution Bionic Cochlear Implant n = 15
Baseline CNC Score	2.13 (7.453)
12 Month Post Implant CNC score	61.14 (20.240)

Population analysed: The primary outcome measure used in this clinical feasibility study was monosyllabic word recognition with the ear to be implanted in quiet using the CNC word test. Subjects that achieved a CNC word recognition score ≤ 30% in the implanted ear and \>30% in the contralateral ear. Subjects are tested using their everyday listening condition for each ear.

Primary outcome: Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)

Time frame: Baseline and Twelve months. Mean (Standard Deviation). Unit: change in decibels (db)

Measure	HiResolution Bionic Cochlear Implant n = 14
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 250 HZ	17.14 (7.774)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 250 HZ	17.14 (8.254)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 500 HZ	17.86 (14.769)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 500 HZ	20.00 (14.005)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 1000 HZ	23.21 (17.277)
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 1000 HZ	25.71 (18.172)
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 2000 HZ	28.57 (21.342)
Pooled Air Conduction Threshold Data for the Contralateral Ear at the 12 Month 2000 HZ	28.93 (20.679)

Population analysed: Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary. • Unaided air conduction thresholds using insert earphones at octave frequencies were measured for non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.

Primary outcome: Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front

Time frame: Baseline and Twelve months. Mean (Standard Deviation). Unit: percentage of recognized words

Measure	HiResolution Bionic Cochlear Implant n = 15
Baseline Pooled AzBio in Noise Data - Speech Front / Noise Front	87.39 (15.382)
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise Front	91.20 (13.08)

Population analysed: Speech recognition in noise was measured with the AZBio speech perception test presented in a background of noise in which the target remained at 0° and noise was presented from 0° (speech front).

Primary outcome: Change in Lateralization Ability Testing (Bilateral Listening Condition)

Time frame: Baseline and Twelve months. Mean (Standard Deviation). Unit: percentage of sentences localized

Measure	HiResolution Bionic Cochlear Implant n = 15
Baseline Pooled Lateralization Ability Data	72 (21.634)
Month 12 Pooled Lateralization Ability Data	89.10 (19.522)

Population analysed: Lateralization ability was measured as the ability to identify the location of a sound presented from a loudspeaker placed at +/- 45° in front of the subject. Test is performed using the participant's bilateral, everyday listening condition using both ears and reported for all subjects at baseline compared to month12.

Adverse events

Time frame: Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HiResolution Bionic Cochlear Implant	0 of 15 (0%)	15 of 15 (100%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hearing Loss

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing HiResolution Bionic Cochlear Implant in people with Hearing Loss and Ear Diseases, run by Advanced Bionics at 2 sites in United States.

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 13 inclusion and 7 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: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 21 Aug 2023). 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?

Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only) (time frame: Baseline and Twelve months). The study lists 6 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 NCT02811549.

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 21 Aug 2023.