Trial Outcomes & Findings for A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study (NCT NCT01715948)
NCT ID: NCT01715948
Last Updated: 2016-04-05
Results Overview
One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.
COMPLETED
NA
9 participants
The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).
2016-04-05
Participant Flow
Participant milestones
| Measure |
Contralateral Routing of Signals (CROS) Hearing Aid
Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.
Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study
Baseline characteristics by cohort
| Measure |
A Comparison Between Wireless CROS and BAHD for SSD
n=8 Participants
Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.
CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
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Age, Continuous
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54 years
n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Region of Enrollment
Canada
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8 participants
n=5 Participants
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PRIMARY outcome
Timeframe: The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.
Outcome measures
| Measure |
QuickSIN Noise to Better Ear Unaided
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
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QuickSIN Noise to Better Ear With BAHD
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
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QuickSIN Noise to Better Ear With CROS
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
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QuickSIN Noise to Poorer Ear Unaided
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
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QuickSIN Noise to Poorer Ear With BAHD
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
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QuickSIN Noise to Poorer Ear With CROS
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
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Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise
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5.44 words
Interval 4.461 to 6.419
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3.5 words
Interval 2.646 to 4.354
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4.75 words
Interval 3.815 to 5.685
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-1.75 words
Interval -2.346 to -1.154
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0.75 words
Interval -0.089 to 1.589
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2.38 words
Interval 1.786 to 2.974
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PRIMARY outcome
Timeframe: Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..Population: The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.
Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.
Outcome measures
| Measure |
QuickSIN Noise to Better Ear Unaided
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
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QuickSIN Noise to Better Ear With BAHD
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
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QuickSIN Noise to Better Ear With CROS
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
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QuickSIN Noise to Poorer Ear Unaided
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
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QuickSIN Noise to Poorer Ear With BAHD
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
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QuickSIN Noise to Poorer Ear With CROS
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
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Percentage of Words Recognized
Unaided Condition
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48.5 Percentage of words perceived correctly
Interval 42.23 to 54.77
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78 Percentage of words perceived correctly
Interval 74.56 to 81.44
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96 Percentage of words perceived correctly
Interval 94.25 to 97.75
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—
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Percentage of Words Recognized
BAHD Condition
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62.5 Percentage of words perceived correctly
Interval 55.81 to 69.19
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77 Percentage of words perceived correctly
Interval 70.97 to 83.03
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97 Percentage of words perceived correctly
Interval 94.77 to 99.23
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—
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—
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Percentage of Words Recognized
CROS Condition
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62 Percentage of words perceived correctly
Interval 57.48 to 66.52
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66.5 Percentage of words perceived correctly
Interval 60.22 to 72.78
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94.5 Percentage of words perceived correctly
Interval 91.85 to 97.15
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PRIMARY outcome
Timeframe: Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 ("Not at all") to 10 ("Perfectly"). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined.
Outcome measures
| Measure |
QuickSIN Noise to Better Ear Unaided
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
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QuickSIN Noise to Better Ear With BAHD
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
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QuickSIN Noise to Better Ear With CROS
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
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QuickSIN Noise to Poorer Ear Unaided
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
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QuickSIN Noise to Poorer Ear With BAHD
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
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QuickSIN Noise to Poorer Ear With CROS
n=8 Participants
Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
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Speech Spatial Qualities Questionnaire (SSQ)
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5.56 units on a scale
Interval 5.112 to 6.008
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5.79 units on a scale
Interval 5.365 to 6.215
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4.24 units on a scale
Interval 3.727 to 4.753
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4.45 units on a scale
Interval 3.702 to 5.198
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6.89 units on a scale
Interval 6.431 to 7.349
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7.12 units on a scale
Interval 6.43 to 7.81
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Adverse Events
BAHD
CROS Aid
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