Evaluation of the Baha SoundArc in Pediatric Patients

• Sponsor: Cochlear (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03333577
• Collaborator: (none)
• Enrollment: 32
• Locations: 3
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to gather clinical performance data on the Baha SoundArc

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Conductive; Hearing Loss, Mixed; Hearing Loss, Unilateral	Device: SoundArc	N/A

Detailed Description

Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Baha SoundArc in Pediatric Patients
• Actual Study Start Date: Nov 2, 2017
• Actual Primary Completion Date: Nov 2, 2018
• Actual Study Completion Date: Nov 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental SoundArc study group all subjects will receive the SoundArc intervention	Device: SoundArc; non-surgical attachment method for wearing a bone conduction hearing system

Outcome Measures

Primary Outcome Measures

1. Patient Satisfaction Survey [one month post fitting]

   To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)

2. Percentage Correct on Word Identification Task [4 weeks post fitting]

   one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months

• Subjects aged 5 through 12 years of age

• Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)

• Willingness on behalf of the subject's parent or guardian to complete study questionnaire

Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Hearing and Balance	Chandler	Arizona	United States	85224
2	Rady Children's Hospital	San Diego	California	United States	92123
3	Cook Children's Hospital	Fort Worth	Texas	United States	76104

Sponsors and Collaborators

• Cochlear

Investigators

• Study Director: George Cire, Study Director

Study Documents (Full-Text)

• Study Protocol - Aug 18, 2017

More Information

Publications

None provided.

• Responsible Party: Cochlear
• ClinicalTrials.gov Identifier: NCT03333577
• Other Study ID Numbers: CAM5714
• First Posted: Nov 7, 2017
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Unilateral; Hearing Loss, Mixed Conductive-Sensorineural

Study Results

Participant Flow

Arm/Group Title	Experimental SoundArc Study Group
Arm/Group Description	all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Period Title: Overall Study
STARTED	32
COMPLETED	25
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Experimental SoundArc Study Group
Arm/Group Description	all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Overall Participants	25
Age (Count of Participants)
<=18 years	25 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	9 36%
Male	16 64%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Patient Satisfaction Survey
Description	To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)
Time Frame	one month post fitting

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental SoundArc Study Group
Arm/Group Description	all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Measure Participants	25
Number [percentage of satisfied subjects]	65

2. Primary Outcome

Title	Percentage Correct on Word Identification Task
Description	one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.
Time Frame	4 weeks post fitting

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental SoundArc Study Group
Arm/Group Description	all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Measure Participants	25
Mean (Standard Deviation) [% corrrect words]	85.1 (13.6)

Adverse Events

Time Frame	Study duration use one month interval. Adverse events were recorded from time of consent/enrollment until completion of study
Adverse Event Reporting Description	Adverse events were recorded from time of consent/enrollment until completion of study
Arm/Group Title	Experimental SoundArc Study Group
Arm/Group Description	all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
All Cause Mortality
	Experimental SoundArc Study Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Experimental SoundArc Study Group
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Experimental SoundArc Study Group
	Affected / at Risk (%)	# Events
Total	1/25 (4%)
Musculoskeletal and connective tissue disorders
irritation from use of Device	1/25 (4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.