Trial Outcomes & Findings for Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding (NCT NCT00582946)
NCT ID: NCT00582946
Last Updated: 2016-11-04
Results Overview
A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.
COMPLETED
PHASE1
16 participants
1 month
2016-11-04
Participant Flow
Participant milestones
| Measure |
Magnetic Contact Hearing Aid
Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
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|---|---|
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Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Baseline characteristics by cohort
| Measure |
Magnetic Contact Hearing Aid
n=16 Participants
Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthA primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.
Outcome measures
| Measure |
Maximum Equivalent Pressure Output
n=16 Participants
Provision of amplification to treat sensorineural hearing loss with direct-drive hearing aid for acute evaluation of efficacy.
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|---|---|
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Maximum Effective Sound Pressure Level (MEPO)
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95 decibels (dB) Sound Pressure Level (SPL)
Standard Deviation 7
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Adverse Events
Magnetic Contact Hearing 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