An interventional study of Remote Fitting and In-Office Fitting in Hearing Loss, Ear Diseases and Hearing Disorders, sponsored by Advanced Bionics. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Advanced Bionics (part of Sonova AG) · Interventional and Treatment
This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 19 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.
Inclusion Criteria Specific to Aidable Residual Hearing Group
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.
Device: Remote Fitting · Device: In-Office Fitting
Device: Remote Fitting · Device: In-Office Fitting
Processors will be programmed using remote fitting application.
Processors will be programmed using standard Target CI application.
Speech Performance in Quiet After Chronic Use (EO Only)
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: 2-3 weeks after fitting
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time frame: Test performed 2-3 weeks after fitting
Investigators recruited study subjects from their clinical practices. The first patient visit occurred on 08/18/21 and last patient visit occurred on 05/23/22. Of the 19 enrolled, 2 were deemed ineligible to continue after visit 1 and 17 subjects were assigned to a study; 12 subjects were enrolled in the EO group and 5 subjects were enrolled in the ARH sub-group based on the results of their audiometric testing. All 17 subjects completed the study, with no withdrawals or losses to follow up.
| Milestone | Electric Only (EO) | Aidable Residual Hearing (ARH) |
|---|---|---|
| Started | 13 | 6 |
| Completed | 12 | 5 |
| Not completed | 1 | 1 |
| Withdrew: Screen fail | 1 | 1 |
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
| percentage of correctly recognized words | Electric Only (EO) |
|---|---|
| In-Office Fitting Speech Perception score | 89.28 ± 3.489 |
| Remote Fitting Speech Perception score | 91.94 ± 2.760 |
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
| percentage of recognized words | EO Group | ARH Group | Overall (Both Groups) |
|---|---|---|---|
| In-Office fitting Evaluation | 89.28 ± 12.088 | 88.46 ± 8.855 | 89.04 ± 10.964 |
| Remote Fitting Evaluation | 91.94 ± 9.562 | 88.72 ± 6.007 | 90.99 ± 8.613 |
Collected over AEs were recorded and tracked between completion of the informed consent form and two weeks after the participant completes the study. This total time period is approximately 6-8 weeks dependent on the subject scheduled visits.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electric Only | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Aidable Residual Hearing | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Event | Electric Only | Aidable Residual Hearing |
|---|---|---|
| Device Implant Failure - Right earEar and labyrinth disorders | 1/12 | 0/5 |
| Migraine HeadacheGeneral disorders | 1/12 | 0/5 |
| Age, Categorical(Participants) | Electric Only | Aidable Residual Hearing (ARH) | Total |
|---|---|---|---|
| <=18 years | 3 | 0 | 3 |
| Between 18 and 65 years | 6 | 3 | 9 |
| >=65 years | 4 | 3 | 7 |
| Age, Continuous(years) | Electric Only | Aidable Residual Hearing (ARH) | Total |
|---|---|---|---|
| Mean | 48.2 (15 to 84) | 66.2 (60 to 78) | 53.8 (15 to 84) |
| Sex: Female, Male(Participants) | Electric Only | Aidable Residual Hearing (ARH) | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 5 | 1 | 6 |
| Race and Ethnicity Not Collected(Participants) | Electric Only | Aidable Residual Hearing (ARH) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Electric Only | Aidable Residual Hearing (ARH) | Total |
|---|---|---|---|
| United States | 13 | 6 | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
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