Recipients With Limited Bimodal Benefit: HA or CROS

NCT ID: NCT04155138

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-03-20

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.

Detailed Description

It is well accepted that bilateral input can significantly improve speech understanding in noise for patients with cochlear implants. For cochlear implant (CI) recipients who have a CI on only one side, two sided input can be provided with simultaneous use of a hearing aid (HA) or a CROS device on the opposite side. The decision about which device to use depends on the level of residual hearing a recipient has in non CI-implanted ear, and more specifically what level of useable residual hearing s/he has. Access to useable low frequency hearing can not only improve speech understanding in noise, it can also improve sound quality, pitch perception and music perception.

Clinicians can reasonably predict that a recipient with hearing thresholds better than 60 dB HL at low frequencies (below 750 Hz) would benefit from amplification. For recipients with no measurable acoustic hearing in the contralateral ear, CROS would be a reasonable option, especially if bilateral implantation is not feasible or desired. However, it is more difficult to predict the appropriate device in individuals who have some measurable acoustic hearing but may be receiving limited benefit from it. This can be especially challenging because audiometric thresholds are not a reliable predictor of bimodal benefit. Additionally, acoustic hearing can provide subjective benefits which could hold different intrinsic value or significance for different individuals depending on their life style and listening needs.

Conditions

Cochlear Implant; Hearing Disability; Hearing Disorders and Deafness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Naida Hearing Aid

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)

Group Type: OTHER

Naida Hearing Aid

Intervention Type: DEVICE

hearing aid

Naida Contralateral Routing of Sound Device

Intervention Type: DEVICE

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

Naida CROS Device

The same cohort will cross over to each arm.

Group Type: OTHER

Naida Hearing Aid

Intervention Type: DEVICE

hearing aid

Naida Contralateral Routing of Sound Device

Intervention Type: DEVICE

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

Interventions

Naida Hearing Aid

hearing aid

Intervention Type: DEVICE

Naida Contralateral Routing of Sound Device

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

Intervention Type: DEVICE

Other Intervention Names

HA; CROS

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Bionics

INDUSTRY

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Ottawa Hospital

Ottawa, ON - Ontario, Canada

Countries

Canada

Central Contacts

Debora L Hogan, M.Sc.N.

Role: CONTACT

dhogan@ohri.ca

6137378899 ext. 72968

David Schramm, MD

Role: CONTACT

dschramm@toh.ca

6137378899 ext. 72968

Facility Contacts

Debora L Hogan, MScN

Role: primary

sisterssejour@hotmail.com

6137378899 ext. 72968

David Schramm, MD

Role: backup

dschramm@toh.ca

6137378899 ext. 72968

Other Identifiers

CRRF 842

Identifier Type: -

Identifier Source: org_study_id