An interventional study of HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode and EAS sound processor in Hearing Loss, Partial Deafness and Hearing Disorders, sponsored by Advanced Bionics. Terminated at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Advanced Bionics (part of Sonova AG) · Not applicable, Interventional, and Treatment
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).
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 67 is above 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.
Inclusion criteria: Newly Implanted Group:
Exclusion Criteria: Newly Implanted Group:
EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups
EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups
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™ 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.
Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode · Device: EAS sound processor
Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
Device: EAS sound processor
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.
Device: EAS sound processor
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).
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.
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)
Time frame: 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.
Time frame: 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.
Time frame: up to 12 months post device activation
Investigators recruited study subjects from their clinical practices. Thirteen study sites enrolled a total of 67 subjects. Of those enrolled, 35 completed the study main phase (month 12). The first patient first visit occurred on June 30, 2014, and last patient last visit occurred on 11/2/2020 for the main phase of the study. Twenty-four of the subjects that completed month 12 volunteered to enroll in the extended use phase. The last visit of the extended use phase was March 29, 2022.
| Milestone | Newly Implanted Group | Existing Implanted Group |
|---|---|---|
| Started | 49 | 18 |
| Completed | 22 | 13 |
| Not completed | 27 | 5 |
| Milestone | Newly Implanted Group | Existing Implanted Group |
|---|---|---|
| Started | 15 | 9 |
| Completed | 0 | 0 |
| Not completed | 15 | 9 |
| Withdrew: Withdrawal by subject | 0 | 4 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Desire to explore other commercial technology/processor upgrade | 11 | 1 |
| Withdrew: Explanted prior to 24 month visit | 1 | 0 |
| Withdrew: Travel issues | 2 | 1 |
| Withdrew: No longer perceiving a benefit from acoustic component | 0 | 3 |
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)
| decibles | Newly Implanted Subjects | Existing Implanted |
|---|---|---|
| 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 |
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.
| Percent words correct | Newly Enrolled | Existing Implanted |
|---|---|---|
| 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 |
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.
| Percent words correct | Newly Enrolled | Existing Implanted |
|---|---|---|
| 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 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Newly Implanted Group | 1/49 (2%) | 16/49 (32.7%) | 24/49 (49%) |
| Existing Implanted Group | 0/18 (0%) | 0/18 (0%) | 9/18 (50%) |
| Extended Use Phase - Newly Implanted Group | 0/15 (0%) | 1/15 (6.7%) | 4/15 (26.7%) |
| Extended Use Phase - Existing Implanted Group | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Event | Newly Implanted Group | Existing Implanted Group | Extended Use Phase - Newly Implanted Group | Extended Use Phase - Existing Implanted Group |
|---|---|---|---|---|
| Postoperative decrease/loss of residual hearingEar and labyrinth disorders | 10/49 | 0/18 | 0/15 | 0/9 |
| Complication at Implant SiteEar and labyrinth disorders | 0/49 | 0/18 | 1/15 | 0/9 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 2/49 | 0/18 | 0/15 | 0/9 |
| Severe inflammation from extensive radiation damageGeneral disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| DeathGeneral disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| Fractured left femoral head secondary to fallMusculoskeletal and connective tissue disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| Fractured rib secondary to fallMusculoskeletal and connective tissue disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| Crushed legs secondary to Motor Vehicle AccidentMusculoskeletal and connective tissue disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| Hospitalization due to Health SetbackGeneral disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| Torn Shoulder TendonMusculoskeletal and connective tissue disorders | 1/49 | 0/18 | 0/15 | 0/9 |
| Event | Newly Implanted Group | Existing Implanted Group | Extended Use Phase - Newly Implanted Group | Extended Use Phase - Existing Implanted Group |
|---|---|---|---|---|
| Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 5/49 | 5/18 | 0/15 | 0/9 |
| Vertigo or DizzinessEar and labyrinth disorders | 12/49 | 1/18 | 0/15 | 0/9 |
| Complication at Implant siteSkin and subcutaneous tissue disorders | 4/49 | 0/18 | 3/15 | 0/9 |
| Post-operative Pain - Implanted earSurgical and medical procedures | 7/49 | 0/18 | 0/15 | 0/9 |
| Musculoskeletal injury, sprain or fractureMusculoskeletal and connective tissue disorders | 6/49 | 1/18 | 0/15 | 0/9 |
| Postoperative decrease/loss of residual hearingEar and labyrinth disorders | 2/49 | 0/18 | 0/15 | 1/9 |
| Tinnitus - Continuous (Bilateral)Ear and labyrinth disorders | 0/49 | 0/18 | 0/15 | 1/9 |
| Device related/ Programming ProblemsProduct Issues | 5/49 | 1/18 | 0/15 | 0/9 |
| Ear Irritation/PainEar and labyrinth disorders | 4/49 | 0/18 | 0/15 | 0/9 |
| HeadachesGeneral disorders | 4/49 | 1/18 | 0/15 | 0/9 |
| Age, Categorical(Participants) | Newly Implanted Group | Existing Implanted Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 12 | 35 |
| >=65 years | 26 | 6 | 32 |
| Age, Continuous(years) | Newly Implanted Group | Existing Implanted Group | Total |
|---|---|---|---|
| Mean | 65 ± 13.95 | 60.3 ± 12.37 | 64 ± 14.4 |
| Sex: Female, Male(Participants) | Newly Implanted Group | Existing Implanted Group | Total |
|---|---|---|---|
| Female | 27 | 6 | 33 |
| Male | 22 | 12 | 34 |
| Race and Ethnicity Not Collected(Participants) | Newly Implanted Group | Existing Implanted Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Newly Implanted Group | Existing Implanted Group | Total |
|---|---|---|---|
| United States | 49 | 18 | 67 |
| Unaided low frequency hearing threshold - EAS Baseline(Hertz (Hz)) | Newly Implanted Group | Existing Implanted Group | Total |
|---|---|---|---|
| Mean | 67 ± 11 | 72.0 ± 19.5 | 69 ± 14.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2014 to primary completion in Mar 2022, 89 months.
Results were first posted in May 2025, 3 years 1 month after primary completion.
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