Trial Outcomes & Findings for Real World Perspectives on Advancements in Hearing Aid Technology (NCT NCT05468918)

Results Overview

A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Day 1 of study

Results posted on

2023-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Tested With Comparator Devices First, Than Audeo Lumity Devices All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices. Phonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces	Participants Tested With Audeo Lumity First, Than Comparator Devices All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices. Phonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	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	All Participants Tested With Both Devices. n=14 Participants Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices.
Age, Continuous	75 years n=14 Participants
Sex: Female, Male Female	8 Participants n=14 Participants
Sex: Female, Male Male	6 Participants n=14 Participants
Region of Enrollment United States	14 Participants n=14 Participants

PRIMARY outcome

Timeframe: Day 1 of study

A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.

Outcome measures

Outcome measures
Measure	All Participants Tested With Both Devices. n=14 Participants Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices.
Speech in Noise Test Percent correct with Lumity devices	84.84 percentage of correct responses Interval 52.5 to 99.0
Speech in Noise Test Percent correct with comparator devices	77.16 percentage of correct responses Interval 24.0 to 98.5

PRIMARY outcome

Timeframe: Day 1 of study

Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.

Outcome measures

Outcome measures
Measure	All Participants Tested With Both Devices. n=14 Participants Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices.
Subjective Perception of Listening Effort Listening effort rating with Lumity devices	5.82 score on a scale Interval 1.0 to 10.0
Subjective Perception of Listening Effort Listening effort rating with comparator devices	6.82 score on a scale Interval 3.0 to 10.0

Adverse Events

All Participants Who Wore Comparator Devices

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Participants Who Wore Audeo Lumity Devices

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

Director of Research

Sonova USCS

Phone: 630-821-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place