Evaluation of Performance and Usability of N6 in the Paediatric Population

Cochlear, Asia Pacific

Status: Unknown

Conditions: Hearing Loss; Transplants and Implants

Treatments: Device: N6

Study type: Interventional

Funder types: Other

Identifiers

NCT01800929

CAP5433

Details and patient eligibility

About

The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.

Full description

This study will evaluate the user benefits of the N6 system in the paediatric population currently equipped with N5. The performance and usability of both systems will be evaluated and compared. The performance of the N6 is expected to be at least equivalent to the N5.

Outcome measures:

• City University of New York (CUNY) Sentence Test in quiet and noise
• Consonant-Nucleus-Consonant (CNC) words in quiet
• in-house designed Usability questionnaires of the N6 system (information to be used internally)
• PEACH, TEACH and SELF questionnaires - developed by Ching & Hill (2007). PEACH - The Parents' Evaluation of Aural/oral performance of Children TEACH - The Teachers' Evaluation of Aural/oral performance of Children for teachers SELF - The Child's Self evaluation of aural/oral performance.

Speech perception tests will be administered at baseline, then again three times, two weeks apart with the N6 processor - i.e. week 0, week 2, week 4 & week 6. Total time: 2 months.

Questionnaires will also be given at the same time points, to get baseline information, as well as N6 information

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 5-14 years, currently using N5
• Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR).
• Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor
• Excellent verbal reporters
• Excellent record of attending clinical appointments.
• Attend a regular school,
• English 1st language.
• Excellent record of compliance with habilitation tasks.

Exclusion criteria

• Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements
• Inability to attend study appointments.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

N6

Experimental group

Description:

The N6 system comprises an investigational sound processor, remote assistant and fitting software

Treatment:

Device: N6

N5

Active Comparator group

Description:

The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design.

Treatment:

Device: N6