Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

Oticon Medical

Status: Completed

Conditions: Hearing Loss, Conductive; Ear Diseases; Conductive Hearing Loss, Unilateral; Hearing Loss Mixed; Conductive Hearing Loss, Bilateral; Hearing Disability; Conductive Hearing Loss

Treatments: Device: Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower; Device: Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower; Device: Collection of Glasgow Benefit Inventory; Device: Collection of speech intelligibility scores; Device: Skin reaction; Device: Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower; Device: Collection of power-on usage time with Ponto 3 SuperPower

Study type: Observational

Funder types: Industry

Identifiers

NCT04803279

BC107

Details and patient eligibility

About

The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits.

The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study.

Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016.

The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower.

The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
2. Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
3. Adult subjects (18 years or older)
4. Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed

Exclusion criteria

There are no exclusion criteria in this study due to the retrospective nature of the study.

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Trial design

57 participants in 1 patient group

Ponto 3 SuperPower users

Description:

Patients who are fitted either unilaterally or bilaterally on abutment since the device came to the market in 2016, and who have followed the clinics normal routine fitting and follow up visits. They must also have undergone the normal procedures performed as part of the clinics routine for fitting and following up. Data was collected from these routine visits.

Treatment:

Device: Collection of power-on usage time with Ponto 3 SuperPower

Device: Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower

Device: Skin reaction

Device: Collection of speech intelligibility scores

Device: Collection of Glasgow Benefit Inventory

Device: Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower

Device: Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower