NCT05086809

Investigation of an Updated Bone-anchored Sound Processor

BC109 - Investigation of an Updated Bone-anchored Sound Processor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor. The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.

Detailed description

The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor. The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included. The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A \& Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence. This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.

Conditions

• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed
• Hearing Disorders
• Deafness
• Ear Diseases
• Otorhinolaryngologic Diseases
• Sensation Disorders
• Neurologic Manifestations
• Nervous System Diseases

Interventions

Type	Name	Description
DEVICE	Device A	Participant wear Device A and evaluate the performance of the device.
DEVICE	Device B	Participant wear Device B and evaluate the performance of the device.

Timeline

• Start date: 2021-09-30
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2021-10-21
• Last updated: 2022-04-20

Locations

1 site across 1 country: Denmark