Severe-to-profound Hearing Loss
Conditions
Brief 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.
Interventions
OTHERObservational study
Sponsors
Advanced Bionics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CI aided word recognition scores in quiet and noise. | 12 months post activation | CI aided word recognition scores in quiet and noise. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the potential of preservation of residual low frequency hearing | 12 months | Evaluate the difference in Pure tone thresholds pre and post implantation in the low frequencies. |
Countries
Netherlands
Outcome results
None listed