Trial Outcomes & Findings for Evaluation of the Baha SoundArc in Pediatric Patients (NCT NCT03333577)

NCT ID: NCT03333577

Last Updated: 2019-04-30

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: one month post fitting
• Results posted on: 2019-04-30

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

25 subjects completed visit 1 and 2 and were analyzed

Baseline characteristics by cohort

Measure	Experimental SoundArc Study Group n=25 Participants all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Age, Categorical <=18 years	25 Participants n=25 Participants • 25 subjects completed visit 1 and 2 and were analyzed
Age, Categorical Between 18 and 65 years	0 Participants n=25 Participants • 25 subjects completed visit 1 and 2 and were analyzed
Age, Categorical >=65 years	0 Participants n=25 Participants • 25 subjects completed visit 1 and 2 and were analyzed
Sex: Female, Male Female	9 Participants n=25 Participants • 25 subjects completed visit 1 and 2 and were analyzed
Sex: Female, Male Male	16 Participants n=25 Participants • 25 subjects completed visit 1 and 2 and were analyzed

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Experimental SoundArc Study Group n=25 Participants all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Patient Satisfaction Survey	65 percentage of satisfied subjects

PRIMARY outcome

Timeframe: 4 weeks post fitting

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

Outcome measures

Measure	Experimental SoundArc Study Group n=25 Participants all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Percentage Correct on Word Identification Task	85.1 % corrrect words Standard Deviation 13.6

Adverse Events

Experimental SoundArc Study Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Experimental SoundArc Study Group n=25 participants at risk all subjects will receive the SoundArc intervention SoundArc: non-surgical attachment method for wearing a bone conduction hearing system
Musculoskeletal and connective tissue disorders irritation from use of Device	4.0% 1/25 • Number of events 1 • Study duration use one month interval. Adverse events were recorded from time of consent/enrollment until completion of study Adverse events were recorded from time of consent/enrollment until completion of study

Additional Information

George Cire

Cochlear

Phone: 303 885 5440

Email: gcire@msn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place