Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Device: Hearing Aid; Device: CROS; Other: Cochlear Implant Alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03867396

18-1101

Details and patient eligibility

About

Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.

This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.

Enrollment: 40 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria*:

• An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
• Low frequency Pure Tone Audiometry (PTA)

Exclusion Criteria*:

• Non-English speakers

  • Additional Inclusion and Exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

Cochlear Implant and Hearing Aid

Active Comparator group

Description:

Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.

Treatment:

Device: Hearing Aid

Cochlear Implant alone

Active Comparator group

Description:

Subject only uses the cochlear implant; hearing on the contralateral side is unaided.

Treatment:

Other: Cochlear Implant Alone

Cochlear Implant and CROS

Experimental group

Description:

Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.

Treatment:

Device: CROS