Trial Outcomes & Findings for Benefits of Assistive Listening Device for Speech Intelligibility (NCT NCT05072470)

NCT ID: NCT05072470

Last Updated: 2023-02-13

Results Overview

The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 1 of a one day study

Results posted on

2023-02-13

Participant Flow

Participant milestones

Participant milestones
Measure
Experimental
Participants with bilateral moderate to severe sensorineural hearing loss Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid
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
Participants with bilateral moderate to severe sensorineural hearing loss Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid
Age, Categorical
<=18 years
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=10 Participants
Age, Categorical
>=65 years
8 Participants
n=10 Participants
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
Bilateral Moderate to Severe Sensorineural Hearing Loss
10 Participants
n=10 Participants

PRIMARY outcome

Timeframe: Day 1 of a one day study

The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.

Outcome measures

Outcome measures
Measure
Experimental
n=10 Participants
Participants with bilateral moderate to severe sensorineural hearing loss Roger microphone: Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. Phonak Audeo hearing aid: Commercially available receiver-in-canal hearing aid
Speech Intelligibility in Noise
Percentage of words correctly repeated with hearing aid only at 0 dB SNR
58 percentage of words correctly repeated
Standard Deviation 26
Speech Intelligibility in Noise
Percentage of words correctly repeated with Roger system at 0 dB SNR
80 percentage of words correctly repeated
Standard Deviation 20
Speech Intelligibility in Noise
Percentage of words correctly repeated with hearing aid only at -5 dB SNR
27 percentage of words correctly repeated
Standard Deviation 17
Speech Intelligibility in Noise
Percentage of words correctly repeated with Roger system at -5 dB SNR
50 percentage of words correctly repeated
Standard Deviation 23
Speech Intelligibility in Noise
Percentage of words correctly repeated with hearing aid only at +5 dB SNR
80 percentage of words correctly repeated
Standard Deviation 22
Speech Intelligibility in Noise
Percentage of words correctly repeated with Roger system at +5 dB SNR
87 percentage of words correctly repeated
Standard Deviation 17

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

Research Audiologist

Sonova USCS

Phone: 630-821-5000

Results disclosure agreements

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

Restriction type: LTE60