NCT05034731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

July 28, 2021

Results QC Date

July 28, 2023

Last Update Submit

August 29, 2023

Conditions

Hearing LossEar DiseasesHearing DisordersOtolaryngological Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Test performed 2-3 weeks after fitting

Study Arms (2)

Electric Only

OTHER
Device: Remote FittingDevice: In-Office Fitting

Aidable Residual Hearing

OTHER
Device: Remote FittingDevice: In-Office Fitting

Interventions

Remote FittingDEVICE

Processors will be programmed using remote fitting application.

Aidable Residual HearingElectric Only
In-Office FittingDEVICE

Processors will be programmed using standard Target CI application.

Aidable Residual HearingElectric Only

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide Informed Consent/Assent
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hearing LossEar DiseasesHearing DisordersOtorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ankur Kaushal, VP of Global Regulatory Affairs
Organization
Advanced Bionics
clinicalresearch@advancedbionics.com
6613621400

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2021

First Posted

September 5, 2021

Study Start

August 18, 2021

Primary Completion

May 23, 2022

Study Completion

May 23, 2022

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)