NCT05859568

Baseline Performance and Fitting Parameters for Sonova Products

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Advanced Bionics · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

Detailed description

This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.

Conditions

• Hearing Loss
• Ear Diseases
• Hearing Disorders
• Otolaryngological Disease

Interventions

Type	Name	Description
DEVICE	Pinna-located microphone	Sound processors using a pinna-located microphone
DEVICE	Pinna-simulated microphone algorithm	Sound processors using a pinna-simulated algorithm

Timeline

• Start date: 2023-04-17
• Primary completion: 2028-04-17
• Completion: 2028-04-17
• First posted: 2023-05-16
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study