Trial Outcomes & Findings for Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System (NCT NCT05034731)

Last Updated: 2023-09-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

2-3 weeks after fitting

Results posted on

2023-09-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Electric Only (EO) 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.	Aidable Residual Hearing (ARH) A group of subjects that met the general study criteria and the inclusion criteria for ARH as follows: * 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
Overall Study STARTED	13	6
Overall Study COMPLETED	12	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Electric Only (EO) 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.	Aidable Residual Hearing (ARH) A group of subjects that met the general study criteria and the inclusion criteria for ARH as follows: * 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
Overall Study Screen fail	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electric Only n=13 Participants 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.	Aidable Residual Hearing (ARH) n=6 Participants 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	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=13 Participants	0 Participants n=6 Participants	3 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=13 Participants	3 Participants n=6 Participants	9 Participants n=19 Participants
Age, Categorical >=65 years	4 Participants n=13 Participants	3 Participants n=6 Participants	7 Participants n=19 Participants
Age, Continuous	48.2 years n=13 Participants	66.2 years n=6 Participants	53.8 years n=19 Participants
Sex: Female, Male Female	8 Participants n=13 Participants	5 Participants n=6 Participants	13 Participants n=19 Participants
Sex: Female, Male Male	5 Participants n=13 Participants	1 Participants n=6 Participants	6 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 participants n=13 Participants	6 participants n=6 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 2-3 weeks after fitting

Outcome measures

Outcome measures
Measure	Electric Only (EO) n=12 Participants 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.	ARH Group 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	Overall (Both Groups) This group includes both the EO and ARH subjects that met inclusion criteria and fitted with an investigational device.
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	—	—
Speech Performance in Quiet After Chronic Use (EO Only) Remote Fitting Speech Perception score	91.94 percentage of correctly recognized words Standard Deviation 2.760	—	—

PRIMARY outcome

Timeframe: Test performed 2-3 weeks after fitting

Outcome measures

Outcome measures
Measure	Electric Only (EO) n=12 Participants 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.	ARH Group n=5 Participants 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	Overall (Both Groups) n=17 Participants This group includes both the EO and ARH subjects that met inclusion criteria and fitted with an investigational device.
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) In-Office fitting Evaluation	89.28 percentage of recognized words Standard Deviation 12.088	88.46 percentage of recognized words Standard Deviation 8.855	89.04 percentage of recognized words Standard Deviation 10.964
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) Remote Fitting Evaluation	91.94 percentage of recognized words Standard Deviation 9.562	88.72 percentage of recognized words Standard Deviation 6.007	90.99 percentage of recognized words Standard Deviation 8.613

Adverse Events

Electric Only

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Aidable Residual Hearing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Electric Only n=12 participants at risk Remote Fitting: Processors will be programmed using remote fitting application. In-Office Fitting: Processors will be programmed using standard Target CI application.	Aidable Residual Hearing n=5 participants at risk Remote Fitting: Processors will be programmed using remote fitting application. In-Office Fitting: Processors will be programmed using standard Target CI application.
Ear and labyrinth disorders Device Implant Failure - Right ear	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/5 • 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.
General disorders Migraine Headache	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/5 • 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.

Additional Information

Ankur Kaushal, VP of Global Regulatory Affairs

Advanced Bionics

Phone: 6613621400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI agrees to submit any publication to Sponsor at least 30 days before submission. Within 30 days, Sponsor advises PI in writing of any information contained therein which is Confidential Information (other than Study Data) or which may impair availability of patent protection for Inventions. Sponsor has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
Publication restrictions are in place

Restriction type: OTHER