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

NCT03078920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-08-11

No results posted yet for this study

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

Interventions

DEVICE

Naída CROS

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.

Sponsors & Collaborators

  • Advanced Bionics AG

    lead INDUSTRY

Principal Investigators

  • Volkmar Hamacher, Dr. · Advanced Bionics GmbH

  • Isabelle MOSNIER, Dr. · Groupe Hospitalier de la PITIE-SALPETRIERE

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2017-07-19
Completion
2017-07-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078920 on ClinicalTrials.gov