Clinical Trials Directory

Trials / Unknown

UnknownNCT04155138

Recipients With Limited Bimodal Benefit: HA or CROS

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICENaida Hearing Aidhearing aid
DEVICENaida Contralateral Routing of Sound DeviceThis is a device that routes sound to the non-cochlear implanted ear.

Timeline

Start date
2019-12-01
Primary completion
2020-12-01
Completion
2021-03-20
First posted
2019-11-07
Last updated
2019-11-07

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04155138. Inclusion in this directory is not an endorsement.