Investigating Hearing With the Ponto 4 a Bone Anchored Hearing Aid

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Oticon Medical
Updated on 21 April 2021

Summary

The study is a prospective, multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.

Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.

The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.

Description

This is a post market clinical follow up (PMCF) study with the purpose of gather knowledge on the use and performance of the Ponto 4 device on existing Ponto 4 users. The study does not include any treatment or fitting of new devices, instead the real-life application of the use of Ponto 4 on subjects already using Ponto 4(s) are investigated.

The Investigational Device used in the study is Ponto 4, a CE marked, and FDA cleared bone anchored hearing solution, produced by Oticon Medical AB and commercially available since June 2019.

The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 4 device as a minimum 1.5 month prior to the study. 20 patients, including minors down to 12 years old, with a conductive, mixed hearing loss or single-sided deafness will be included. The rationale for including minors is that they are also users of the device, and it is found important to collect data from their experience of using the device as well.

The study is a prospective, multi-center study. It has one visit of 2,5-3 hours for adult subjects 18 years old. To minimize the burden and risks of tiredness for the minor subjects from 12-17 years old, the protocol activities can be divided into two visits. The decision will be based on the Investigators discretion.

The majority of the objectives of the study are prospectively collected whereas the BC In-situ (hearing with the Ponto 4 on) and audiometric data from the time of the fitting of Ponto 4, are collected retrospectively from the time of the fitting of Ponto 4.

The overall objectives of the study are to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear(s), in terms of the subject's ability to hear sounds and understand speech when using the device.

The primary endpoint is to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear for patients within intended use.

These will be evaluated through a hearing and a speech test, both assessing the hearing with the Ponto 4(s) both on and off. Additionally, the subject will complete 2 patient reported outcome, report daily usage time of the device and assess satisfaction of connectivity devices.

Minimal risks are expected for subjects participating in the study. Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics. The measurements will require an extra effort and may be found slightly tiring by the subject. To mitigate the risk of tiredness the subject will be given the opportunity to have breaks during the visit.

Details
Condition Mixed conductive and sensorineural hearing loss, Conductive hearing loss, mixed hearing loss
Treatment Audiometry
Clinical Study IdentifierNCT04761926
SponsorOticon Medical
Last Modified on21 April 2021

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note