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

NCT04803279 | Completed Results

• 1 other identifier: BC107
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  Visit 2, 3 months

Secondary Outcomes (8)

• Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.

  Visit 1, Day 1

• Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL

  Visit 2, 3 months

• Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD

  Visit 2, 3 months

• 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

• Quality of Life Improvements With the Ponto 3 SuperPower

  Visit 2, 3 months

Study Arms (1)

Ponto 3 SuperPower users

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.

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

Interventions

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

Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.

Ponto 3 SuperPower users

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

BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted

Ponto 3 SuperPower users

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

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

Ponto 3 SuperPower users

Collection of speech intelligibility scores DEVICE

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.

Ponto 3 SuperPower users

Skin reaction DEVICE

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

Ponto 3 SuperPower users

Collection of Glasgow Benefit Inventory DEVICE

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.

Ponto 3 SuperPower users

Collection of power-on usage time with Ponto 3 SuperPower DEVICE

Average power-on usage hours from Ponto 3 SuperPower will be collected.

Ponto 3 SuperPower users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data collected from patients, who are Ponto 3 SuperPower users, and who have attended the Audiology Clinic at Norfolk and Norwich University Hospital (NNUH),Colney Ln, Norwich NR4 7UY, UK, in the period 2016-2020

You may qualify if:

• 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.
• Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
• Adult subjects (18 years or older)
• 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

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Ear Diseases

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Amichetti, PhD, MS, Manager of Clinical Affairs
• Organization: Oticon Medical

nitc@oticonmedical.com

6093660424

Study Officials

• John E FitzGerald, Bsc Phd

  Norfolk & Norwich University Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: March 16, 2021
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)