Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Advanced Bionics

ClinicalTrials.gov Identifier:

NCT00205881

First received: September 13, 2005

Last updated: February 28, 2012

Last verified: February 2012

History of Changes

Results First Received: September 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hearing Loss
Intervention:	Device: HiRes 90K Bionic Ear System

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Bilaterally Implanted	31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.

Participant Flow: Overall Study

	Bilaterally Implanted
STARTED	32
COMPLETED	16 ^[1]
NOT COMPLETED	16
Withdrawal by Subject	16

[1]	32 enrolled. 1 unilateral. 25 bilateral for data analysis at 8 months. 16 completed study.

Baseline Characteristics

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Reporting Groups

	Description
Bilaterally Implanted	31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.

Baseline Measures

	Bilaterally Implanted
Number of Participants [units: participants]	32
Age [units: participants]
<=18 years	0
Between 18 and 65 years	27
>=65 years	5
Age [units: years] Mean ± Standard Deviation	52.6 ± 12.56
Gender [units: participants]
Female	21
Male	11
Region of Enrollment [units: participants]
United States	32

Outcome Measures

1. Primary:

Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. [ Time Frame: 8 months of bilateral cochlear implant use ]

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2. Secondary:

HINT Sentences in Noise [ Time Frame: 8 months of bilateral cochlear implant use ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigators were not permitted to disclose study results until the Sponsor had completed data analyses and report generation for regulatory purposes, and/or received regulatory approval. The Sponsor agreed to notify the Investigators when they were free to publish, present or use any results arising out of this study for their own instructional, research, or publication objectives, provided that such publication did not disclose any of the Sponsor's proprietary information.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Kenneth Ripley
Organization: Advanced Bionics, LLC
phone: (661) 362-4572 ext N/A
e-mail: Kenneth.Ripley@advancedbionics.com

No publications provided

Responsible Party:	Advanced Bionics
ClinicalTrials.gov Identifier:	NCT00205881 History of Changes
Other Study ID Numbers:	AUD-BL-070705
Study First Received:	September 13, 2005
Results First Received:	September 29, 2011
Last Updated:	February 28, 2012
Health Authority:	United States: Institutional Review Board

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