Trial Outcomes & Findings for Home Test of New Sound Processor (NCT NCT04559282)
NCT ID: NCT04559282
Last Updated: 2021-11-22
Results Overview
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
COMPLETED
NA
16 participants
Day 0, day 7 and day 14
2021-11-22
Participant Flow
16 participants were recruited in one centre from 23 September 2020 to 27 November 2020.
Participant milestones
| Measure |
Baha 6 Max Followed by Baha 5 SP Followed by Unaided Hearing
Participants received Baha 6 Max followed by Baha 5 SP followed by Unaided
|
Baha 5 SP Followed by Baha 6 Max Followed by Unaided Hearing
Participants received Baha 5 SP followed by Baha 6 Max followed by Unaided
|
|---|---|---|
|
Intervention 1 (Day 0)
STARTED
|
8
|
8
|
|
Intervention 1 (Day 0)
COMPLETED
|
8
|
8
|
|
Intervention 1 (Day 0)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (Day 7)
STARTED
|
8
|
8
|
|
Intervention 2 (Day 7)
COMPLETED
|
8
|
8
|
|
Intervention 2 (Day 7)
NOT COMPLETED
|
0
|
0
|
|
Intervention 3 (Day 14)
STARTED
|
8
|
8
|
|
Intervention 3 (Day 14)
COMPLETED
|
8
|
8
|
|
Intervention 3 (Day 14)
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 |
Entire Study Population
n=16 Participants
Crossover, participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=16 Participants
|
|
Region of Enrollment
Sweden
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Day 0, day 7 and day 14Population: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
|
-3.7 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 2.75
|
4.8 db SNR (decibel Speech in Noise Ratio)
Standard Deviation 6.55
|
PRIMARY outcome
Timeframe: Day 14Population: Participants received Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
|
13 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 7 and day 14Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 7 followed by Baha 5 SP or Baha 6 Max at day 14
Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor.
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Daily use 10-16 hours
|
13 Participants
|
9 Participants
|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Daily use 6-8 hours
|
2 Participants
|
6 Participants
|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Daily use > 16 hours
|
1 Participants
|
1 Participants
|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Change battery in device
|
2 Participants
|
8 Participants
|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
No change battery in device
|
14 Participants
|
8 Participants
|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Change to their own SP
|
4 Participants
|
3 Participants
|
|
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
No change to their own SP
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 0 and day 7Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
|
-3.7 dB SNR
Standard Deviation 2.75
|
-2.8 dB SNR
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Day 0 and day 7Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz\]
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
250 Hz
|
29.7 db HL (decibel Hearing Level)
Standard Deviation 7.2
|
34.1 db HL (decibel Hearing Level)
Standard Deviation 8.2
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
500 Hz
|
20.9 db HL (decibel Hearing Level)
Standard Deviation 9.4
|
24.1 db HL (decibel Hearing Level)
Standard Deviation 10.8
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
1000 Hz
|
20.3 db HL (decibel Hearing Level)
Standard Deviation 8.8
|
23.1 db HL (decibel Hearing Level)
Standard Deviation 10.5
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
2000 Hz
|
23.4 db HL (decibel Hearing Level)
Standard Deviation 11.4
|
25.3 db HL (decibel Hearing Level)
Standard Deviation 12.7
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
3000 Hz
|
29.1 db HL (decibel Hearing Level)
Standard Deviation 15.4
|
33.4 db HL (decibel Hearing Level)
Standard Deviation 15.7
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
4000 Hz
|
35 db HL (decibel Hearing Level)
Standard Deviation 14.1
|
37.5 db HL (decibel Hearing Level)
Standard Deviation 16.2
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
6000 Hz
|
36.9 db HL (decibel Hearing Level)
Standard Deviation 15.2
|
39.7 db HL (decibel Hearing Level)
Standard Deviation 17.4
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
8000 Hz
|
35.3 db HL (decibel Hearing Level)
Standard Deviation 120.0
|
56.9 db HL (decibel Hearing Level)
Standard Deviation 22.0
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
9000 Hz
|
36.3 db HL (decibel Hearing Level)
Standard Deviation 20.0
|
65.3 db HL (decibel Hearing Level)
Standard Deviation 12.6
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
10000 Hz
|
50.6 db HL (decibel Hearing Level)
Standard Deviation 19.8
|
65.3 db HL (decibel Hearing Level)
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Day 0 and day 7Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
|
88.4 Percentage of correct words
Standard Deviation 14.4
|
77.9 Percentage of correct words
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: Day 14Population: No data for speech understanding on sound clip 2 and for sound clarity on sound clip 1.
Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips.
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Loudness- sound clip 1
|
3.0 Score on a scale
Standard Deviation 0.5
|
2.6 Score on a scale
Standard Deviation 0.5
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Loudness- sound clip 2
|
2.8 Score on a scale
Standard Deviation 0.9
|
2.6 Score on a scale
Standard Deviation 0.6
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Artefacts- sound clip 1
|
4.69 Score on a scale
Standard Deviation 0.8
|
4.63 Score on a scale
Standard Deviation 1.1
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Artefacts- sound clip 2
|
4.69 Score on a scale
Standard Deviation 0.5
|
4.5 Score on a scale
Standard Deviation 1.0
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Speech understanding- sound clip 1
|
4.38 Score on a scale
Standard Deviation 0.89
|
3.63 Score on a scale
Standard Deviation 1.1
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Sound quality- sound clip 1
|
4.25 Score on a scale
Standard Deviation 0.9
|
3.31 Score on a scale
Standard Deviation 1.2
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Sound quality- sound clip 2
|
4.31 Score on a scale
Standard Deviation 0.7
|
3.44 Score on a scale
Standard Deviation 1.2
|
|
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Sound clarity-sound clip 2
|
4.31 Score on a scale
Standard Deviation 0.9
|
3.19 Score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Day 14Participant rating Yes or No for internal noise after listening to sound clips.
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Sound clip 1-No
|
15 Participants
|
16 Participants
|
|
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Sound clip 1-Yes
|
1 Participants
|
0 Participants
|
|
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Sound clip 2-Yes
|
0 Participants
|
0 Participants
|
|
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Sound clip 2-No
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: Data are for sound clip 1. No data available for sound clip 2.
Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort.
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
|
1.97 Score on a scale
Standard Deviation 1.9
|
3.02 Score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Day 0, day 7 and day 14Population: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.
Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz\]
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
250 Hz
|
29.7 db HL (decibel Hearing Level)
Standard Deviation 7.2
|
46.3 db HL (decibel Hearing Level)
Standard Deviation 13.6
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
500 Hz
|
20.9 db HL (decibel Hearing Level)
Standard Deviation 9.4
|
49.7 db HL (decibel Hearing Level)
Standard Deviation 12.0
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
1000 Hz
|
20.3 db HL (decibel Hearing Level)
Standard Deviation 8.8
|
54.4 db HL (decibel Hearing Level)
Standard Deviation 12.6
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
2000 Hz
|
23.4 db HL (decibel Hearing Level)
Standard Deviation 11.4
|
50.6 db HL (decibel Hearing Level)
Standard Deviation 50.6
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
3000 Hz
|
29.1 db HL (decibel Hearing Level)
Standard Deviation 15.4
|
55.3 db HL (decibel Hearing Level)
Standard Deviation 16.4
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
4000 Hz
|
35.0 db HL (decibel Hearing Level)
Standard Deviation 14.1
|
64.1 db HL (decibel Hearing Level)
Standard Deviation 17.8
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
6000 Hz
|
36.9 db HL (decibel Hearing Level)
Standard Deviation 15.2
|
65.0 db HL (decibel Hearing Level)
Standard Deviation 18.4
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
8000 Hz
|
35.3 db HL (decibel Hearing Level)
Standard Deviation 20.0
|
65.6 db HL (decibel Hearing Level)
Standard Deviation 17.3
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
9000 Hz
|
36.3 db HL (decibel Hearing Level)
Standard Deviation 21.2
|
70.0 db HL (decibel Hearing Level)
Standard Deviation 15.5
|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
10000 Hz
|
50.6 db HL (decibel Hearing Level)
Standard Deviation 19.8
|
72.2 db HL (decibel Hearing Level)
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Day 0, day 7 and day 14Population: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words
Outcome measures
| Measure |
Baha 6 Max
n=16 Participants
Baha 6 Max SP
|
Unaided
n=16 Participants
Unaided hearing
|
|---|---|---|
|
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
|
88.4 Percentage of correct words
Standard Deviation 14.4
|
11 Percentage of correct words
Standard Deviation 21.8
|
Adverse Events
Baha 6 Max
Baha 5
Unaided
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