Trial Outcomes & Findings for Effect of Hearing Aid Labeling on Speech Understanding Measures (NCT NCT05274178)
NCT ID: NCT05274178
Last Updated: 2023-07-10
Results Overview
A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB.
COMPLETED
NA
20 participants
Day 1 of 1 day study
2023-07-10
Participant Flow
Participant milestones
| Measure |
Naive Listeners
Participants who have not worn hearing aids before. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive".
Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
|
Experienced Users
Participants who have at least 6 months experience with hearing aids. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive".
Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Tested With "OTC" Labeled Devices
|
10
|
10
|
|
Overall Study
Tested With "Prescriptive" Laeled Devices
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
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
| Measure |
Naive Listeners
n=10 Participants
Participants who have not worn hearing aids before. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive".
Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
|
Experienced Users
n=10 Participants
Participants who haveat least 6 months of experience with hearing aids. These participants will be tested with both sets of Audeo P hearing aids. One set will be labeled as "OTC" and the other set will be labeled as "Prescriptive".
Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=10 Participants
|
76.8 years
n=10 Participants
|
73.4 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Day 1 of 1 day studyPopulation: All participants who were tested with the devices labeled as "OTC" and with devices that were labeled as "Prescriptive" in the same test session.
A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB.
Outcome measures
| Measure |
Naive Listeners
n=10 Participants
Participants who have never worn a hearing aid before. This group will be tested with both sets of devices, those labeled as "OTC" and those labeled as "Prescriptive"
Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
|
Experienced Users
n=10 Participants
Participants who have at least six months experience wearing hearing aids. This group will be tested with both sets of devices, those labeled as "OTC", and those labeled as "Prescriptive"
Audeo P hearing aid labeled as "Prescriptive": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
Audeo P hearing aid labeled as "OTC": The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
|
|---|---|---|
|
Quick Speech in Noise Test (QuickSIN)
dB SNR with "OTC" labelled devices
|
6.2 decibels (dB)
Interval 2.0 to 12.0
|
9.6 decibels (dB)
Interval 3.0 to 15.0
|
|
Quick Speech in Noise Test (QuickSIN)
dB SNR with "Prescriptive" labelled devices
|
5.2 decibels (dB)
Interval 1.0 to 11.0
|
10 decibels (dB)
Interval 2.0 to 18.0
|
Adverse Events
Naive Listeners
Experienced Users
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principle Investigator
Phonak Audiology Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place