A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
ConditionHearing Loss Mixed
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuance Hearing
About this trial
Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
Perceived mild to moderate hearing loss as indicated by at least 1 positive answer to any of the signs specified by FDA: a) You have trouble hearing speech in noisy places, b) You find it hard to follow speech in groups, c) You have trouble hearing on the phone. d) Listening makes youtired, e) You need to turn up the volume on the TV or radio, and other people complain it's too loud
Wearing corrective glasses for daily use
Cognitive ability to understand and follow study instructions.
Disqualifiers
Hearing loss >55 dB HL
Prior hearing aid usages for the last 12 months
Medical history of cognitive or neurological impairment.
Active inflammatory conditions affecting the ear
Trial design
Design model
Single group
Treatments tested in this trial
Spectacle Hearing Aid
Devicewearing hearing aid for effectiveness assessment by hearing tests and questionnaires
Treatment groups
89 Participants
are divided into 1 treatment groupGroup A: ActiveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Spectacle Hearing Aid effectiveness
Difference in SNR-50 when performed unaided versus aided using Spectacle Hearing Aid
Time frame
2 weeks2
Spectacle Hearing Aid safety
Incidence of device or procedure related adverse events
Time frame
2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nuance Hearing
Lead sponsor
Assuta Medical Center
Collaborator
Source ClinicalTrials.gov