Multicenter evaluation of Neurelec Digisonic® SP cochlear implant reliability

Area of Science:

• Audiology
• Biomedical Engineering
• Otolaryngology

Background:

• Universal newborn hearing screening enables earlier cochlear implant (CI) detection.
• Increased CI use necessitates long-term device reliability data for informed choices.
• Assessing the latest generation Digisonic® SP CI's performance is crucial.

Purpose of the Study:

• To evaluate the reliability of the Neurelec Digisonic® SP CI in children and adults.
• To determine the 5-year failure rate (FR) and cumulative survival rate (CSR) of this device.
• To provide data supporting clinical and patient device selection.

Main Methods:

• A multicenter retrospective study involving nine CI centers.
• Data collected via questionnaire for 672 patients implanted between 2006 and 2011.
• Calculation of FR and CSR over a 5-year period for Digisonic® SP recipients.

Main Results:

• Overall explantation rate was 2.23% (15/672) over 5 years.
• Device failure accounted for 0.89% (6/672) of explantations.
• The 5-year CSR was high: 98.51% overall, 98.48% in children, and 98.57% in adults.

Conclusions:

• The Digisonic® SP CI demonstrates excellent 5-year reliability in both pediatric and adult populations.
• Low failure rates support its suitability for long-term use in cochlear implantation.
• This study offers valuable independent data for clinicians and patients choosing cochlear implant devices.