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Investigation of an Updated Bone-anchored Sound Processor

NCT05086809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-04-20

No results posted yet for this study

Summary

The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.

The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.

Conditions

  • Hearing Loss
  • Hearing Loss, Conductive
  • Hearing Loss, Mixed
  • Hearing Disorders
  • Deafness
  • Ear Diseases
  • Otorhinolaryngologic Diseases
  • Sensation Disorders
  • Neurologic Manifestations
  • Nervous System Diseases

Interventions

DEVICE

Device A

Participant wear Device A and evaluate the performance of the device.

DEVICE

Device B

Participant wear Device B and evaluate the performance of the device.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Mona El Hichou, MSc · Oticon Medical c/o Oticon A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2021-12-13
Completion
2021-12-13

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05086809 on ClinicalTrials.gov