Evaluation of the efficacy of the VOLTA 1.0 software suite in adults implanted with the HarmonyTM HiResolutionTM Bionic Ear Cochlear Implant system

Evaluation of the efficacy of the VOLTA 1.0 software suite in adults implanted with the HarmonyTM HiResolutionTM Bionic Ear Cochlear Implant system - VOLTA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38476

Enrollment

Registered

2013-10-14

Start date

2013-11-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deafness severe to profound hearing disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18 years of age or older • Willingness to participate in the scheduled procedures outlined in the protocol

Exclusion criteria

Exclusion criteria: • Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures • Pregnancy at time of surgery as confirmed by pregnancy test.

Design outcomes

Primary

Measure	Time frame
punt 1.5 - 1.9 pagina 18-21 Primary Efficacy Endpoint • Collect clinical data on the efficacy of the automated NRI paradigms (NRI-express) to evaluate non inferiority of automated vs. visual NRI measurement and non-inferiority of automated vs. manual NRI measurement. • Evaluate equivalence of NRI-express and manual NRI procedures Primary Safety Endpoint N/A , as Safety of the software has already been proven by the software Safety validation.	—

Measure

Time frame

punt 1.5 - 1.9 pagina 18-21 Primary Efficacy Endpoint • Collect clinical data on the efficacy of the automated NRI paradigms (NRI-express) to evaluate non inferiority of automated vs. visual NRI measurement and non-inferiority of automated vs. manual NRI measurement. • Evaluate equivalence of NRI-express and *manual* NRI procedures Primary Safety Endpoint N/A , as Safety of the software has already been proven by the software Safety validation.

—

Secondary

Measure	Time frame
punt 1.5 - 1.9 pagina 18-21	—

Countries

Netherlands

Outcome results