An interventional study of Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software and 301-M062 sound processor & software in Hearing Loss, Ear Diseases and Hearing Disorders, sponsored by Advanced Bionics. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.
Sponsored by Advanced Bionics (part of Sonova AG) · Not applicable, Interventional, and Treatment
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 22 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.
General Inclusion Criteria:
ARH Arm Inclusion Criteria
EO Arm Inclusion Criteria
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.
Control Device followed by experimental Device.
Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software · Device: 301-M062 sound processor & software
Control Device followed by experimental Device.
Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software · Device: 301-M062 sound processor & software
Control cochlear implant sound processor
New cochlear implant sound processor
Speech Recognition in Quiet
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: 1 Day
Speech Recognition in Noise
Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: 1 Day
Increased Speech Recognition in Noise
Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: 1 Day
Investigators recruited study subjects from their clinical practices. The first patient first visit occurred on December 17, 2019 and last patient last visit occurred on October 15, 2020. A total of 22 subjects were enrolled; 10 subjects were enrolled in the Electric Only cohort and 12 subjects were enrolled in the Aidable Residual Hearing cohort based on the results of their audiometric testing. All 22 subjects completed the study; there were no withdrawals or losses to follow-up.
| Milestone | Electric Only (EO) Cohort | Aidable Residual Hearing (ARH) Cohort |
|---|---|---|
| Started | 10 | 12 |
| Completed | 10 | 12 |
| Not completed | 0 | 0 |
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
| percentage of correct words | EO Cohort | ARH Cohort |
|---|---|---|
| Baseline AutoSound | 88.31 ± 5.817 | 89.39 ± 10.535 |
| Baseline AutoSense | 87.30 ± 10.214 | 88.09 ± 9.848 |
Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
| percentage of correct word responses | EO Cohort | ARH Cohort |
|---|---|---|
| AutoSound | 52.95 ± 31.163 | 66.04 ± 25.939 |
| AutoSense | 76.37 ± 19.078 | 84.98 ± 13.108 |
Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
| percentage of correct words recognized | EO Cohort | ARH Cohort |
|---|---|---|
| Omnidirectional | 42.93 ± 30.801 | 51.37 ± 28.604 |
| AutoSense | 76.37 ± 19.078 | 84.98 ± 13.108 |
Collected over 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. The total period is up to 5 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EO Cohort | 0/10 (0%) | 0/10 (0%) | 2/10 (20%) |
| ARH Cohort | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | EO Cohort | ARH Cohort |
|---|---|---|
| Upper RespiratoryInfections and infestations | 1/10 | 0/12 |
| Sprained ankleMusculoskeletal and connective tissue disorders | 1/10 | 0/12 |
| Patient discomfortProduct Issues | 0/10 | 1/12 |
Subject assigned to ARH cohort were residual low frequency hearing sensitivity (PTA of \< 70 dB HL for 125 thru 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1000 thru 8000 Hz) in the implanted ear. EO cohort assigned to subjects with Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125 thru 500 Hz) and high frequencies (PTA ≥ 70 dB HL for 1000 thru 8000 Hz) in the implanted ear
| Age, Categorical(Participants) | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 3 | 9 |
| >=65 years | 6 | 7 | 13 |
| Age, Continuous(years) | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| Mean | 61.1 ± 9.66 | 67.2 ± 9.28 | 64.5 ± 9.74 |
| Sex: Female, Male(Participants) | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 3 | 5 | 8 |
| Race and Ethnicity Not Collected(Participants) | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| United States | 12 | 10 | 22 |
| Audiometric Threshold Testing and Speech Perception Testing(Participants) | Aidable Residual Hearing (ARH) Cohort | Electric Only (EO) Cohort | Total |
|---|---|---|---|
| Count of participants | 12 | 10 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
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