Trials / Completed

CompletedNCT04803279

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 57 (actual)

Sponsor: Oticon Medical · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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).

Conditions

Interventions

Type	Name	Description
DEVICE	Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower	Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.
DEVICE	Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower	BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted
DEVICE	Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower	Sound field thresholds for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz will be collected from sound field audiogram obtained as follow-up after Ponto 3 SuperPower fitting, typically this is collected 3 months post fitting, alternatively from the fitting visit. Thresholds will be obtained aided, and when available unaided
DEVICE	Collection of speech intelligibility scores	Speech intelligibility is measured in a sound treated room using sentence tests. The sentence tests used at Norwich and Norfolk hospital is the BKB (Bamford-Kowal-Bench) and/or the The AB\[s\] Isophonemic Monosyllabic Word test (7). The sentence tests are measured in quiet and/or with background speech-weighted noise.
DEVICE	Skin reaction	Classification of skin reactions around skin penetrating implants will be made using the Holgers score. The Holgers classification is a scale from 0 to 4 that is used to grade skin reactions
DEVICE	Collection of Glasgow Benefit Inventory	The Glasgow Benefit Inventory (GBI) contains 18 health status questions, which ask specific questions about how the health problem, in this study hearing loss, has affected their quality of life at the time the GBI is completed. In this study GBI has been collected on patients before intervention and 3 months after fitting of Ponto 3 SuperPower on abutment.
DEVICE	Collection of power-on usage time with Ponto 3 SuperPower	Average power-on usage hours from Ponto 3 SuperPower will be collected.

Timeline

Start date: 2021-03-16
Primary completion: 2021-06-08
Completion: 2021-06-08
First posted: 2021-03-17
Last updated: 2025-08-26
Results posted: 2025-08-26

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04803279. Inclusion in this directory is not an endorsement.