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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 18 and 65
Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.
Must not have
Subjects who are not native speakers of English.
Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing special computer programs in a wearable device to help people who use hearing aids understand speech better. The device adjusts sound volume based on how loud the sounds are, making it easier to hear quiet sounds without making loud sounds too loud.
Who is the study for?
This trial is for English-speaking adults aged 18-65 with bilateral, symmetric sensorineural hearing loss that's less than 75 dB at low frequencies. It excludes non-native English speakers, those with normal or mixed hearing loss, asymmetric hearing loss, and severe loss above 70 dB at higher frequencies.
What is being tested?
The study tests the Tympan device to see how its nonlinear signal processing algorithms affect speech understanding in people with certain types of hearing loss.
What are the potential side effects?
Since this trial involves a non-invasive device designed to improve speech perception, side effects are minimal but may include discomfort from wearing the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
My hearing loss in both ears is less than 75 dB at low tones.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
English is not my first language.
Select...
My hearing is normal or I have mixed or uneven hearing loss.
Select...
I am younger than 18 or older than 65.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Speech understanding
Secondary study objectives
Preference
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Perceptual measuresExperimental Treatment1 Intervention
Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for sensorineural hearing loss (SNHL) include hearing aids, cochlear implants, and auditory processing technologies like nonlinear signal processing algorithms. Hearing aids amplify sound to make it more accessible to damaged auditory pathways.
Cochlear implants bypass damaged hair cells in the cochlea, directly stimulating the auditory nerve. Nonlinear signal processing algorithms enhance speech perception by selectively amplifying speech signals while reducing background noise.
These mechanisms are crucial for SNHL patients as they improve the clarity and intelligibility of sounds, thereby enhancing communication abilities and overall quality of life.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,219,008 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a native English speaker.English is not my first language.My hearing is normal or I have mixed or uneven hearing loss.You have hearing loss that is worse than 70 decibels at 2000 Hertz and below.I am younger than 18 or older than 65.I am between 18 and 65 years old.My hearing loss in both ears is less than 75 dB at low tones.
Research Study Groups:
This trial has the following groups:- Group 1: Perceptual measures
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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