An interventional study of HiResolution Bionic Cochlear Implant in Hearing Loss, Ear Diseases and Hearing Disorders, sponsored by Advanced Bionics. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Advanced Bionics (part of Sonova AG) · Not applicable, Interventional, and Treatment
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).
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 24 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Advanced Bionics is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
First submitted after Advanced Bionics AG became part of Sonova AG.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Requirements:
Ear to be Implanted:
Contralateral (non-implanted) ear:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: HiResolution Bionic Cochlear Implant
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Twelve Months
Investigators recruited study subjects from their clinical practices. The first patient first visit occurred on November 7, 2016 and last patient last visit occurred on March 25, 2020. Two study sites enrolled a total of 24 subjects in the study. Of the 24 subjects enrolled 15 were deemed eligible to undergo surgical implantation and 14 completed the study. All enrolled subjects provided informed consent.
| Milestone | HiResolution Bionic Cochlear Implant |
|---|---|
| Started | 24 |
| Completed | 14 |
| Not completed | 10 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Subject screen failed | 4 |
| Withdrew: Surgery denied by subject's insurance carrier | 2 |
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.
| percentage of recognized words | HiResolution Bionic Cochlear Implant |
|---|---|
| Baseline CNC Score | 2.13 ± 7.453 |
| 12 Month Post Implant CNC score | 61.14 ± 20.240 |
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 decibels (db) | HiResolution Bionic Cochlear Implant |
|---|---|
| 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 |
| Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 4000 HZ | 35.00 ± 29.483 |
| Pooled Air Conduction Threshold Data for the Contralateral Earat the 12 Month 4000 HZ | 37.86 ± 31.483 |
| Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 8000 HZ | 34.29 ± 31.736 |
| Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 8000 HZ | 40.36 ± 38.203 |
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.
| percentage of recognized words | HiResolution Bionic Cochlear Implant |
|---|---|
| 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 |
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.
| percentage of sentences localized | HiResolution Bionic Cochlear Implant |
|---|---|
| Baseline Pooled Lateralization Ability Data | 72 ± 21.634 |
| Month 12 Pooled Lateralization Ability Data | 89.10 ± 19.522 |
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.
| percentage of recognized words | HiResolution Bionic Cochlear Implant |
|---|---|
| Baseline Pooled AzBio in Noise Data - Speech Front / Noise to Implanted Ear | 92.15 ± 15.689 |
| Month 12 Pooled AzBio in Noise Data - Speech Front / Noise to Implanted Ear | 93.01 ± 10.165 |
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.
| percentage of recognized words | HiResolution Bionic Cochlear Implant |
|---|---|
| Baseline Pooled AzBio in Noise Data - Speech Front / Noise to Contralateral Ear | 82.24 ± 19.318 |
| Month 12 Pooled AzBio in Noise Data - Speech Front / Noise to Contralateral Ear | 89.10 ± 19.522 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HiResolution Bionic Cochlear Implant | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Event | HiResolution Bionic Cochlear Implant |
|---|---|
| Residual hearing loss with a PTA greater than 30dBEar and labyrinth disorders | 9/15 |
| Vertigo or DizzinessGeneral disorders | 7/15 |
| Numbness, discomfort, or pain at or around the pinnaEar and labyrinth disorders | 4/15 |
| Soreness, Tenderness, or Pain at or around the incision siteGeneral disorders | 4/15 |
| Taste DisturbanceGeneral disorders | 4/15 |
| Moderate Tinnitus, continuous - Right EarEar and labyrinth disorders | 2/15 |
| Severe Tinnitus - Left EarEar and labyrinth disorders | 2/15 |
| Severe Tinnitus - Right earEar and labyrinth disorders | 2/15 |
| Complication at implant siteSurgical and medical procedures | 1/15 |
| Mild Tinnitus, intermittent - Left EarEar and labyrinth disorders | 1/15 |
Subjects determined eligible for implantation were implanted ear had severe to profound sensorineural hearing (SNHL) loss (PTA \> 70 dB HL for 500, 1000, 2000, and 4000 Hz) where SNHL duration was \> 3 months and ≤10 year. A moderate SNHL of \< 70 dB HL PTA at 500, 1000, 2000, and 4000 Hz was also present in the contralateral (non-implanted) ear. The Consonant-Nucleus-Consonant Word (CNC) word recognition score for both ears was 30% (tested in subject's everyday listening condition for that ear).
| Age, Categorical(Participants) | HiResolution Bionic Cochlear Implant |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 2 |
| Age, Continuous(years) | HiResolution Bionic Cochlear Implant |
|---|---|
| Mean | 52.0 ± 10.1 |
| Sex: Female, Male(Participants) | HiResolution Bionic Cochlear Implant |
|---|---|
| Female | 11 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | HiResolution Bionic Cochlear Implant |
|---|
| Region of Enrollment(Participants) | HiResolution Bionic Cochlear Implant |
|---|---|
| United States | 15 |
| Audiometric Threshold Testing(dB HL) | HiResolution Bionic Cochlear Implant |
|---|---|
| Pre-Implant PTA (Ear to be implanted) | 92.1 ± 21.1 |
| Pre-Implant PTA (Contralateral Ear) | 26.0 ± 18.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2016 to primary completion in Mar 2020, 40 months.
Results were first posted in Aug 2023, 3 years 4 months after primary completion.
Of 125 industry-sponsored interventional studies with no phase under Hearing Loss, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's 40 months is above that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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