Clinical trial NCT04803279: Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
Official title: Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss, Conductive
Hearing Loss Mixed
Hearing Disability
Conductive Hearing Loss
Ear Diseases
Conductive Hearing Loss, Bilateral
Conductive Hearing Loss, Unilateral
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be collected from patients, who are Ponto 3 SuperPower users, and who have attended the Audiiology Clinic at Norfolk and Norwich University Hospital (NNUH),Colney Ln, Norwich NR4 7UY, UK, in the period 2016-2020

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).


Eligibility criteria: 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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Primary outcomes:
measure: To investigate the improvement in hearing with the Ponto 3 SuperPower for patients with CHL/MHL.
timeFrame: Visit 2, 3 months
Secondary outcomes:
measure: To investigate the improvement in hearing with the Ponto 3 SuperPower for patients with CHL/MHL.
timeFrame: Visit 1, Day 1
measure: 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
timeFrame: Visit 2, 3 months
measure: To assess the speech recognition in noise with Ponto 3 SuperPower on for patients with SSD
timeFrame: Visit 2, 3 months
measure: 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.
timeFrame: After study completion, 6 months
measure: To assess the quality of life with the Ponto 3 SuperPower
timeFrame: Visit 2, 3 months
measure: To evaluate the above objectives on individual levels
timeFrame: After study completion, 6 months
measure: To assess the air to bone gap (PTA4) on the implanted ear(s) for patients with CHL/MHL
timeFrame: After study completion, 6 months
measure: To assess the skin condition around the abutment
timeFrame: Visit 2, 3 months
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
Study officials:
affiliation: Norfolk & Norwich University Hospital NHS Foundation Trust
name: John E FitzGerald, Bsc Phd
role: PRINCIPAL_INVESTIGATOR
References: