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

• Conditions: Hearing Loss Mixed; Hearing Loss, Conductive; Conductive Hearing Loss; Conductive Hearing Loss, Unilateral; Hearing Disability; Conductive Hearing Loss, Bilateral; Ear Diseases
• Interventions: Device: Collection of Pure tone thresholds from audiogram measured prior to fitting of 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 Aided sound field thresholds measured with the Ponto 3 SuperPower; Device: Collection of speech intelligibility scores; Device: Skin reaction; Device: Collection of Glasgow Benefit Inventory; Device: Collection of power-on usage time with Ponto 3 SuperPower

• Registration Number: NCT04803279
• Lead Sponsor: Oticon Medical

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study Start: 2021-03-16
• Study First Posted: 2021-03-17
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Primary Completion: 2021-05-16
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ponto 3 SuperPower users	Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.
Ponto 3 SuperPower users	Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.
Ponto 3 SuperPower users	Skin reaction	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.
Ponto 3 SuperPower users	Collection of Glasgow Benefit Inventory	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.
Ponto 3 SuperPower users	Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.
Ponto 3 SuperPower users	Collection of speech intelligibility scores	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.
Ponto 3 SuperPower users	Collection of power-on usage time with Ponto 3 SuperPower	Patients who are fitted either unilaterlaly or bilatterally on abutment since the device came to the market in 2016, and who have follwoed 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 will be collected from these routine visits.

Primary Outcome Measures

Name	Time	Method
To investigate the improvement in hearing with the Ponto 3 SuperPower for patients with CHL/MHL.	Visit 2, 3 months	Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds and aided sound field thresholds as the average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz

Secondary Outcome Measures

Name	Time	Method
To assess the improvement of speech recognition in quiet and in noise with Ponto 3 SuperPower on the implanted ear(s) for patients with CHL/MHL	Visit 2, 3 months	1. Difference in speech recognition (%) for speech recognition in quiet between unaided and aided.; 2. Difference in speech recognition (%) for speech recognition in noise between unaided and aided.
To assess the speech recognition in noise with Ponto 3 SuperPower on for patients with SSD	Visit 2, 3 months	Difference in speech recognition score (%) for speech recognition in noise between unaided and aided when speech is directed to the aided ear, and noise is directed to the non-implanted ear, and when speech is directed to the non-implanted ear, and when noise is directed to the aided ear.
To assess the quality of life with the Ponto 3 SuperPower	Visit 2, 3 months	Collected summarised scores from the questionnaire Glasgow Benefit Inventory (GBI)
To assess the air to bone gap (PTA4) on the implanted ear(s) for patients with CHL/MHL	After study completion, 6 months	The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencies 500, 1000 and 2000 Hz from audiogram measured in connection with the fitting of Ponto 3 SuperPower
To investigate the improvement in hearing with the Ponto 3 SuperPower for patients with CHL/MHL.	Visit 1, Day 1	Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds and aided sound field thresholds for frequencies 500, 1000, 2000, 3000 and 4000 Hz
To assess the skin condition around the abutment	Visit 2, 3 months	Holgers score (scale 0-4)
To assess the degree to which the Ponto 3 SuperPower compensates for the BC hearing loss on the implanted ear(s) for patients with CHL/MHL.	After study completion, 6 months	Effective gain with Ponto 3 SuperPower, i.e. the difference between aided sound field thresholds and the BC In-situ thresholds on the aided ear(s) measured when the Ponto 3 SuperPower(s) was fitted. The effective gain is calculated as the average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz.
To evaluate the above objectives on individual levels	After study completion, 6 months	First 4 mentioned endpoints analyzed as the proportion of subjects whose performance is better or equal in the unaided to aided comparisons, i.e. have a difference ≥0

Trial Locations

Locations (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom