Trial Outcomes & Findings for Benefit of Assistive Listening Device for Lateralization (NCT NCT05072457)

Results Overview

Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 1 of 1 day study

Results posted on

2023-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=10 Participants All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Age, Continuous	74 years n=10 Participants
Sex: Female, Male Female	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day 1 of 1 day study

Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)

Outcome measures

Outcome measures
Measure	Experimental n=10 Participants All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Lateralization Hearing Ability % Correct using Roger On microphone	71 percent correct responses Interval 53.33 to 100.0
Lateralization Hearing Ability % Correct using Roger Select microphone	54 percent correct responses Interval 26.67 to 73.33

PRIMARY outcome

Timeframe: Day 1 of 1 day study

Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)

Outcome measures

Outcome measures
Measure	Experimental n=10 Participants All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Roger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids Roger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Spatial Hearing Ability % Correct using Roger On microphone	48 percentage of words correctly repeated Interval 7.78 to 72.5
Spatial Hearing Ability % Correct using Roger Select microphone	42 percentage of words correctly repeated Interval 5.1 to 73.75

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lead Investigator

Hearts for Hearing

Phone: 405-548-4335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place