Ear Diseases, Hearing Disorders, Hearing Loss, Otolaryngological Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERemote Fitting
Processors will be programmed using remote fitting application.
DEVICEIn-Office Fitting
Processors will be programmed using standard Target CI application.
Sponsors
Advanced Bionics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All Subjects * Ability to provide Informed Consent/Assent * 13 years of age or older * Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D) * Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor * At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1) * Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16) * English language proficiency as determined by the Investigator * Willingness to use a BTE sound processor for the duration of the study Inclusion Criteria Specific to Aidable Residual Hearing Group * Residual low frequency hearing sensitivity (pure tone average of \< 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects * Willingness to use an in-canal acoustic earhook for the duration of the study
Exclusion criteria
* Clinical presentation indicative of potential implanted device malfunction * Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator * Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Performance in Quiet After Chronic Use (EO Only) | 2-3 weeks after fitting | 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. |
| Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | Test performed 2-3 weeks after fitting | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Per protocol, a subject is considered enrolled upon giving written informed consent. After undergoing the ICF process, subjects completed a hearing test. Depending on the outcome of that test, eligible subjects were enrolled for aidable residual hearing (ARH) fitting with an acoustic earhook. Unilaterally implanted subjects not meeting ARH fitting criteria were enrolled for electric only (EO) fitting. Bilaterally implanted subjects meeting ARH criteria only in one ear were screen failed.
Participants by arm
| Arm | Count |
|---|---|
| Electric Only Any subject that did not meet the ARH fitting criteria was enrolled in the EO fitting group. The EO group were fit with the investigational processor and an Advanced Bionics T-mic for the duration of the study. All subjects (both EO and ARH) underwent the same testing procedures after appropriately fitted. | 13 |
| Aidable Residual Hearing (ARH) Includes subjects that met all general inclusion criteria and hearing inclusion criteria specific for ARH group.
* Residual low frequency hearing sensitivity (pure tone average of \< 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
* Willingness to use an in-canal acoustic earhook for the duration of the study | 6 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen fail | 1 | 1 |
Baseline characteristics
| Characteristic | Aidable Residual Hearing (ARH) | Total | Electric Only |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical >=65 years | 3 Participants | 7 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 9 Participants | 6 Participants |
| Age, Continuous | 66.2 years | 53.8 years | 48.2 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 19 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 5 |
| other Total, other adverse events | 2 / 12 | 0 / 5 |
| serious Total, serious adverse events | 0 / 12 | 0 / 5 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electric Only (EO) | Speech Performance in Quiet After Chronic Use (EO Only) | In-Office Fitting Speech Perception score | 89.28 percentage of correctly recognized words | Standard Deviation 3.489 |
| Electric Only (EO) | Speech Performance in Quiet After Chronic Use (EO Only) | Remote Fitting Speech Perception score | 91.94 percentage of correctly recognized words | Standard Deviation 2.76 |
p-value: <0.0001t-test, 1 sided
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electric Only (EO) | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | In-Office fitting Evaluation | 89.28 percentage of recognized words | Standard Deviation 12.088 |
| Electric Only (EO) | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | Remote Fitting Evaluation | 91.94 percentage of recognized words | Standard Deviation 9.562 |
| ARH Group | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | In-Office fitting Evaluation | 88.46 percentage of recognized words | Standard Deviation 8.855 |
| ARH Group | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | Remote Fitting Evaluation | 88.72 percentage of recognized words | Standard Deviation 6.007 |
| Overall (Both Groups) | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | In-Office fitting Evaluation | 89.04 percentage of recognized words | Standard Deviation 10.964 |
| Overall (Both Groups) | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | Remote Fitting Evaluation | 90.99 percentage of recognized words | Standard Deviation 8.613 |
p-value: <0.0001t-test, 1 sided