Trial Outcomes & Findings for Predicting Success With Hearing Aids (NCT NCT00371449)
NCT ID: NCT00371449
Last Updated: 2015-04-29
Results Overview
The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.
COMPLETED
120 participants
aided (after wearing hearing aids for at least 3 months)
2015-04-29
Participant Flow
Participant milestones
| Measure |
Hearing-Aid Users
Individuals who wore hearing aids for \> 3 months and at their current setting for at least 1 month
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predicting Success With Hearing Aids
Baseline characteristics by cohort
| Measure |
Hearing Aid Users
n=120 Participants
Hearing aid users
|
|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
|
degree of hearing loss
|
36.3 dB HL
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
unaided Words-In-Noise Test
|
14.4 dB S/N
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
unaided Acceptable Noise Level test
|
15.5 dB
STANDARD_DEVIATION 7.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: aided (after wearing hearing aids for at least 3 months)The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.
Outcome measures
| Measure |
Group 1
n=120 Participants
hearing aid users
|
|---|---|
|
Words-in-noise Test
|
12.6 dB S/N
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: aided (after wearing hearing aids for at least 3 months)The ANL consists of a speech signal and a competing noise signal. The speech signal is a continuous monologue (Arizona Travelogue) by a male talker and the competing noise signal is the 12-talker babble from the Speech in Noise (SPIN) test (Kalikow et al, 1977). The speech and babble stimuli are recorded on separate channels on a compact disc (CD; Cosmos, Inc.). The task of the listener was to adjust the level of the travelogue to the most comfortable level (MCL) and then to adjust the level of the babble to the level the listener is willing "to put up with" and still follow the travelogue, or to the background noise level (BNL). The ANL (in dB) is the difference between the MCL and BNL.
Outcome measures
| Measure |
Group 1
n=120 Participants
hearing aid users
|
|---|---|
|
Acceptable Noise Level Test
|
13.5 dB
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: aided (after wearing hearing aids for at least 3 months)Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.
Outcome measures
| Measure |
Group 1
n=120 Participants
hearing aid users
|
|---|---|
|
International Outcomes Inventory for Hearing Aids (IOI-HA)
|
28.9 units on a scale (points)
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: aided (after wearing hearing aids for at least 3 months)Measures hearing-aid self-efficacy over four subscales (basic handling, advanced handling, adjustment, and aided listening). Subscale scores are averaged to produce a total self-efficacy scores that can range from 0 (low self-efficacy) to 100 (high self-efficacy).
Outcome measures
| Measure |
Group 1
n=120 Participants
hearing aid users
|
|---|---|
|
Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
|
84.7 % level of self-efficacy
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: aided (after wearing hearing aids for at least 3 months)Measures how satisfied listeners are with their current hearing aids. Total scale scores are computed by averaging the subscale (positive effect, negative features, personal image, and service \& delivery) scores that range from 1 (no satisfaction) to 7 (high satisfaction).
Outcome measures
| Measure |
Group 1
n=120 Participants
hearing aid users
|
|---|---|
|
Satisfaction With Amplification in Daily Life (SADL)
|
5.4 units on a scale (points)
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: aided (after wearing hearing aids for at least 3 months)The SSQ measures hearing abilities related to speech, spatial perception, and quality of sound using a 1-10 scale. Items are averaged across the test. Higher scores indicate better outcomes.
Outcome measures
| Measure |
Group 1
n=120 Participants
hearing aid users
|
|---|---|
|
Speech Spatial and Qualities of Hearing Scale (SSQ)
|
7.2 units on a scale (points)
Standard Deviation 1.4
|
Adverse Events
Hearing-aid Users
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place