Trial Outcomes & Findings for Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids. (NCT NCT00727909)

NCT ID: NCT00727909

Last Updated: 2014-06-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 290 participants
• Primary outcome timeframe: At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)
• Results posted on: 2014-06-10

Participant Flow

Participants were recruited from Veterans scheduled for audiology appointments at the three participating VA sites: Nashville, Tennessee, Bay Pines, Florida, and Mountain Home, Tennessee. Recruitment occurred during the time period May, 2009 through February, 2011.

All study participants were assigned into all three hearing aid treatments: Traditional Custom TC, Receiver-in-the Aid (RITA), Receiver-in-the-Ear (RITE). The sequence of treatments was counter-balanced to prevent an order effect. Eleven participants who consented withdrew or were excluded prior to the first condition hearing aid fitting.

Participant milestones

Measure	TC RITE RITA Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.	TC RITA RITE Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.	RITE RITA TC Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.	RITA RITE TC Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
Overall Study STARTED	65	72	67	75
Overall Study COMPLETED	60	61	58	70
Overall Study NOT COMPLETED	5	11	9	5

Reasons for withdrawal

Measure	TC RITE RITA Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.	TC RITA RITE Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.	RITE RITA TC Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.	RITA RITE TC Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
Overall Study Withdrawal by Subject	5	11	8	5
Overall Study Death	0	0	1	0

Baseline Characteristics

Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.

Baseline characteristics by cohort

Measure	All Study Participants n=290 Participants All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants
Age, Categorical >=65 years	184 Participants n=5 Participants
Age, Continuous	67.9 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	283 Participants n=5 Participants
Region of Enrollment United States	290 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)

Outcome measures

Measure	All Participants n=249 Participants All participants received all three hearing aid treatments.
Percentage of Participants That Selected a Particular Type of Hearing Aid Percentage of participants preferring TC	15 percentage of participants
Percentage of Participants That Selected a Particular Type of Hearing Aid Percentage of participants preferring RITE	38 percentage of participants
Percentage of Participants That Selected a Particular Type of Hearing Aid Percentage of participants preferring RITA	47 percentage of participants

Adverse Events

All Study Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Study Participants n=290 participants at risk All participants received all three hearing aid treatments.
Cardiac disorders Congestive heart failure	0.34% 1/290 • 1 year, 10 months. The investigators at all 3 VA sites conducted their roles in this investigation under the purview of the local Institutional Review Board(IRB) at each site. The investigators, through their mandatory training, were fully cognizant of the significance of and procedures for reporting any adverse event that could have but did not occur.

Other adverse events

Adverse event data not reported

Additional Information

Gene W. Bratt, Ph.D.

VA TVHS

Phone: 615-873-6068

Email: gene.bratt@va.gov

Results disclosure agreements

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