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

Severe-to-profound Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824563
• Other study ID #: AB-RCA-01-2013
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: January 8, 2018
• Start date: June 2013
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Advanced Bionics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education.

• Local language proficiency

• Bilateral, sensorineural hearing loss

Exclusion Criteria:

• Previous inner ear surgery or active middle ear pathology.

• Cochlear malformation or obstruction

• Presence of additional disabilities that would prevent or interfere with participation in the required study procedures

• Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures

• Evidence of central auditory lesion or compromised auditory nerve

• Concurrent participation in other study

Related Conditions & MeSH terms

• Hearing Loss
• Severe-to-profound Hearing Loss

Intervention

Other:
• Observational study

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Centre	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics AG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the potential of preservation of residual low frequency hearing	Evaluate the difference in Pure tone thresholds pre and post implantation in the low frequencies.	12 months
Primary	CI aided word recognition scores in quiet and noise.	CI aided word recognition scores in quiet and noise.	12 months post activation