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

Completed

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

• 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

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study Start: 2021-03-16
• Study First Posted: 2021-03-17
• Primary Completion: 2021-06-08
• Study Completion: 2021-06-08
• Results First Submitted: 2022-11-04
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Results First Posted: 2025-08-26
• Last Update Posted: 2025-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).	Visit 2, 3 months	Functional gain is the difference between the average unaided threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz and the average aided (i.e. with the Ponto 3 SuperPower) threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz.; For bilaterally fitted patients, the best ear is selected.

Secondary Outcome Measures

Name	Time	Method
Functional Gain 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. For bilaterally fitted patients, the best ear is selected.
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL	Visit 2, 3 months	Aided speech recognition (% correct words) measured in quiet and in noise with the BKB sentence test and the AB\[s\] short list test averaged across patients. Only participants with data for both visits were included in analysis.
Speech Recognition in Noise Improvements 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.; Aided and unaided speech recognition (% correct words) measured with the AB\[s\] short list.
Individual Level Evaluation of Objectives 1-6; Improved Hearing	Change between visit 1 (day 1) and visit 2 (3 months)t of study	Improved hearing was analyzed as the percentage of subjects whose performance is better or equal in the unaided to aided comparisons, i.e., have a difference ≥0.; Functional gain was used for CHL/MHL patients and speech recognition in noise was used for SSD patients.
Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL	Visit 1 day 1	The difference between masked (if not available unmasked) BC and AC thresholds (unaided), denoted 'air to bone gap', calculated for frequencies 500, 1000, and 2000 Hz for the patients with CHL/MHL within indication on the implanted ear. For bilateral patients, the best ear was selected. Only participants that had complete data for these frequencies were included in the analysis.
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.	visit 2, 3 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. Only participants with data for both study visits were included in the analysis.
Quality of Life Improvements With the Ponto 3 SuperPower	Visit 2, 3 months	Glasgow Benefit Inventory (GBI) total score per target population.; The GBI consists of 18 items, each on a 5 point Likert scale. Responses are scaled and averaged to give a score with a range -100 (poorest outcome) through 0 (no change) to +100 (best outcome).
Skin Condition Assessment Around the Abutment	Visit 2, 3 months	Skin condition around the abutment was assessed via Holgers score (scale 0-4).; Holgers 0: No skin reaction Holgers 1: Redness with slight swelling Holgers 2: Redness, moistness, and moderate swelling Holgers 3: Redness, moistness, and moderate swelling with tissue granulation Holgers 4: Profound signs of infection, resulting in removal of the implant; Only participants who had recorded Holgers score in record were analyzed.

Trial Locations

Locations (1)

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