NCT04155138

Brief Summary

The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

October 18, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

October 18, 2018

Last Update Submit

November 4, 2019

Conditions

Cochlear ImplantHearing DisabilityHearing Disorders and Deafness

Keywords

cochlear implanthearing aidcros devicebimodal

Outcome Measures

Primary Outcomes (3)

  • Perception of speech by way of audiogram and AzBio word testing.

    Change in perception of speech by way of audiogram (hearing threshold across dB and frequencies) and AzBio word testing (% accuracy).

    At Baseline, Week 6 and Week 12

  • 7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS

    Change in 7 point Likert study-specific scales illuminating subjective feedback of experience using HA or CROS. 1 (very dissatisfied) to 7 (very satisfied)

    At Baseline, Week 6 and Week 12

  • Participant narrative illuminating subjective feedback of experience using HA or CROS

    Evolution of narrative interview themes illuminating subjective feedback of experience using HA or CROS

    At Baseline, Week 6 and Week 12

Secondary Outcomes (1)

  • Demographics

    At Baseline

Study Arms (2)

Naida Hearing Aid

OTHER

Adults (\> 18 years of age) * Unilaterally implanted with an Advanced Bionics implant (CII or later) * At least six months of CI use experience * Limited bimodal benefit as perceived by the recipient and/or the clinician * Participants may or may not currently be using a hearing aid in the unimplanted ear. * Open set performance with current device configuration: * ≥40% AzBio sentence score in quiet (S0) * If currently bimodal: * Hearing aid ear only CNC score \<50% * AzBio Scores bimodal benefit \<15% * Unaided audiometric threshold of ≤100 dBHL up to 500 Hz * Ability and willingness to participate in multiple sets of open speech testing (and chronically evaluate HA and CROS benefit)

Device: Naida Hearing AidDevice: Naida Contralateral Routing of Sound Device

Naida CROS Device

OTHER

The same cohort will cross over to each arm.

Device: Naida Hearing AidDevice: Naida Contralateral Routing of Sound Device

Interventions

Naida Hearing AidDEVICE

hearing aid

Also known as: HA
Naida CROS DeviceNaida Hearing Aid
Naida Contralateral Routing of Sound DeviceDEVICE

This is a device that routes sound to the non-cochlear implanted ear.

Also known as: CROS
Naida CROS DeviceNaida Hearing Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\> 18 years of age)
  • Unilaterally implanted with an Advanced Bionics implant (CII or later)
  • At least six months of CI use
  • Limited bimodal benefit as perceived by the recipient and/or the clinician
  • Participants may or may not currently be using a hearing aid in the unimplanted ear.
  • Open set performance with current device configuration:
  • ≥40% AzBio sentence score in quiet (S0) and? (i.e. do both these apply)
  • If currently bimodal:
  • Hearing aid ear only CNC score \<50%
  • AzBio Scores bimodal benefit \<15% increase in score compared to CI only?
  • Unaided audiometric threshold of ≤100 dBHL up to 500 Hz
  • Ability and willingness to participate in multiple sets of open speech testing (and ongoing evaluation of HA and CROS benefit)

You may not qualify if:

  • Patients who are not proficient in English as the AzBio testing is available in English only.
  • Patients with agenesis of the contralateral ear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, ON - Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Hearing DisordersDeafness

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss

Central Study Contacts

Debora L Hogan, M.Sc.N.

CONTACT

6137378899dhogan@ohri.ca

David Schramm, MD

CONTACT

6137378899dschramm@toh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Naida Hearing Aid Naida CROS Device
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

November 7, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2020

Study Completion

March 20, 2021

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)