Acceptance of the CP950 Sound Processor

NCT ID: NCT03613909

Last Updated: 2023-09-28

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

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Repeated measures, single-subject experiment. Each subject received the same treatment.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All participants

At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear and at least 3 months experience with the CP810,CP920 or CP910 sound processor.

Group Type EXPERIMENTAL

CP950 OTE Sound processor

Intervention Type DEVICE

CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor

Interventions

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CP950 OTE Sound processor

CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Native speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone

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. Nucleus 22 Implant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CLTD5591

Identifier Type: -

Identifier Source: org_study_id

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