Usability of the CP950 Sound Processor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.

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Detailed Description

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One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod

Group Type EXPERIMENTAL

CP950 Sound Processor

Intervention Type DEVICE

An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor

Wireless programming pod

Intervention Type DEVICE

The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software

Interventions

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CP950 Sound Processor

An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor

Intervention Type DEVICE

Wireless programming pod

The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
2. Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Ability to use 2 zinc air batteries with their current program (MAP)
5. Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial

Exclusion Criteria

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Implant types not currently supported by the CP950 sound processor (i.e.,N22)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes