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

NCT03867396 | Completed Results FDA Device

• 1 other identifier: 18-1101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss, Sensorineural

Keywords

Cochlear Implant; Hearing Loss; Hearing Aids; Hearing Tests

Outcome Measures

Primary Outcomes (3)

• Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.

  The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  12 minutes

• CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.

  The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  12 minutes

• CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.

  The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.

  12 minutes

Study Arms (3)

Cochlear Implant and Hearing Aid

ACTIVE COMPARATOR

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.

Device: Hearing Aid

Cochlear Implant alone

ACTIVE COMPARATOR

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

Other: Cochlear Implant Alone

Cochlear Implant and CROS

EXPERIMENTAL

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

Device: CROS

Interventions

CROS DEVICE

Advanced Bionics CROS

Cochlear Implant and CROS

Hearing Aid DEVICE

Advanced Bionics Naida hearing aid

Cochlear Implant and Hearing Aid

Cochlear Implant Alone OTHER

No hearing device on contralateral ear

Cochlear Implant alone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speakers

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Interventions

Hearing Aids; Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids; Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Prostheses and Implants

Limitations and Caveats

A questionnaire related to listening effort and acceptability ratings was removed from the study and not collected. Outcome measures related to this questionnaire were not collected and have been removed from the record.

Results Point of Contact

• Title: Dr. Melinda Anderson
• Organization: University of Colorado Anschutz SOM

melinda.anderson@cuanschutz.edu

303-724-9316

Study Officials

• Melinda Anderson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 8, 2019
• Study Start: January 23, 2019
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From first patient through Institutional Review Board (IRB) study close.
• Access Criteria: The de-identified data will be shared to with Advanced Bionics in a password protected Excel sheet downloaded from research database.

Locations

US (1)