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Procedure
Phonak Lyric self-replacement procedure for Neonatal Hearing Loss
N/A
Waitlist Available
Research Sponsored by Sonova AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 months
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates if people who use the Phonak Lyric hearing aid can safely and effectively replace it themselves, instead of needing a healthcare professional.
Eligible Conditions
- Neonatal Hearing Loss
- Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in aided audiometric threshold testing between standard and experimental replacement procedures
Change in aided speech-in-noise testing between standard and experimental replacement procedures
Secondary study objectives
Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures
Other study objectives
Change in incidence of acoustic feedback across device replacement procedures
Change in incidence of provider/clinical support needed across device replacement procedures
Change in measured device position at replacement between standard and experimental replacement procedures
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: Lyric self-replacementExperimental Treatment1 Intervention
This cohort of experienced Lyric patients are required to meet the candidacy criteria to be eligible for the self-replacement procedure. They will also be required to demonstrate proficiency with the self-replacement procedure before proceeding with independent self-replacement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phonak Lyric self-replacement procedure
2022
N/A
~60
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Who is running the clinical trial?
Sonova AGLead Sponsor
80 Previous Clinical Trials
1,871 Total Patients Enrolled
AccuData SolutionsUNKNOWN
Grace Gardner, AuDStudy DirectorSonova USA Inc
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