Benefits of a Contralateral Routing of Signals (CROS) System in Unilateral CI-recipients

NCT03078920 | Completed

• 1 other identifier: ABIntl-16-04
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to investigate the new Naida CROS device in adult recipients including chronic phases and to generate some preliminary pre-launch data. The formal study objectives are to compare the speech intelligibility in quiet and noise when using the CROS device with the Naida CI Q70 processor versus the Naida CI processor alone in quiet and noise conditions. Subjects will be tested with and without CROS at the baseline visit and then at follow-up visits taking place one month and three months after baseline. Subjects will use the new device at home between the first two visits appointments and then will only use the Naida CI processor for two additional weeks to better evaluate the handicap of not having access to contralateral signal input. There will be four visits to the centre in total. Subjective feedback will be collected through questionnaire like the APHAB and Speech, Spatial and Qualities of Hearing Scale (SSQ). A customised questionnaire focusing usability and benefit of the CROS will also be administered. Additional interest of the study will be to evaluate any acclimatisation effect with the CROS device both objectively and subjectively.

Conditions

Cochlear Implants

Outcome Measures

Primary Outcomes (6)

• Speech Reception Threshold (SRT) measured with an adaptive test (French Matrix sentence test)

  Speech tests in quiet \& noise with the Naída CI processor alone and with the Naída CROS device

  Baseline

• Speech Reception Threshold (SRT) measured with an adaptive test (French Matrix sentence test)

  Speech tests in quiet \& noise with the Naída CI processor alone and with the Naída CROS device

  1 month

• Speech Reception Threshold (SRT) measured with an adaptive test (French Matrix sentence test)

  Speech tests in quiet \& noise with the Naída CI processor alone and with the Naída CROS device

  3 months

• Speech Reception Threshold (SRT) measured with an adaptive test (French Matrix sentence test)

  Questionnaires about Naída CI sound processor and Naída CROS device listening condition

  Baseline

• Speech Reception Threshold (SRT) measured with an adaptive test (French Matrix sentence test)

  Questionnaires about Naída CI sound processor and Naída CROS device listening condition

  1 month

• Speech Reception Threshold (SRT) measured with an adaptive test (French Matrix sentence test)

  Questionnaires about Naída CI sound processor and Naída CROS device listening condition

  3 months

Secondary Outcomes (8)

• Questionnaires about Naída CI sound processor listening condition

  Baseline

• Questionnaires about Naída CI sound processor listening condition

  Baseline

• Questionnaires about Naída CI sound processor listening condition

  1 months

• Questionnaires about Naída CI sound processor listening condition

  1 months

• Questionnaires about Naída CI sound processor listening condition

  3 months

Study Arms (1)

11 unilateral adult cochlear implant users

OTHER

Speech Reception Threshold (SRT) measured with an adaptive test

Device: Naída CROS

Interventions

Naída CROS DEVICE

At fitting Naída CROS and a loaner Naída CI processor are used for the duration of the study. The fitting software allows to enable a HIBAN link between the CI processor and the Naída CROS. The fitting of the CI processor is based on the clinical programming of the subject. No changes are made to the fitting parameters unless the subject requests changes. The fitting is done according to the clinical routine. The Naída CROS is pre-configured to communicate with the Naída CI when switched on.

11 unilateral adult cochlear implant users

Eligibility Criteria

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

You may qualify if:

• Age of 18 years or older
• Unilaterally implanted with an Advanced Bionics Clarion or HiRes90k (implant type) implant
• At least 6 months of cochlear implant use
• At least 3 months experience with the Naída CI processor
• No benefit or limited benefit with a contralateral hearing aid
• Minimum speech understanding level in quiet of 30% (Lafon lists)
• Ability to wear the Naída CROS device on their contralateral ear and to have sufficient dexterity and understanding to handle both the Naída CI and CROS devices
• Able to describe the sound quality that they receive
• French language proficiency

You may not qualify if:

• Persons mentioned in the following articles of the French public health code: articles from L. 1121-5 to L.1121-8
• Participating in another clinical study
• Difficulties additional to hearing impairment that would interfere with the study procedures

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Groupe Hospitalier de la PITIE-SALPETRIERE

Paris, 75013, France

Location

Study Officials

• Volkmar Hamacher, Dr.

  Advanced Bionics GmbH

  STUDY CHAIR

• Isabelle MOSNIER, Dr.

  Groupe Hospitalier de la PITIE-SALPETRIERE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 14, 2017
• Study Start: March 23, 2017
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)