NCT01824563

Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing

Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Advanced Bionics AG · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.

Conditions

• Severe-to-profound Hearing Loss

Interventions

Type	Name	Description
OTHER	Observational study

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2013-04-05
• Last updated: 2018-01-09

Locations

1 site across 1 country: Netherlands