Clinical trial NCT04761926: Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Official title: Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Conductive
Hearing Loss, Mixed
Keywords: Hearing loss
hearing disorder,
ear diseases
BAHS
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is a prospective, multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.

Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.

The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.

Detailed description: This is a post market clinical follow up (PMCF) study with the purpose of gather knowledge on the use and performance of the Ponto 4 device on existing Ponto 4 users. The study does not include any treatment or fitting of new devices, instead the real-life application of the use of Ponto 4 on subjects already using Ponto 4(s) are investigated.

The Investigational Device used in the study is Ponto 4, a CE marked, and FDA cleared bone anchored hearing solution, produced by Oticon Medical AB and commercially available since June 2019.

The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 4 device as a minimum 1.5 month prior to the study. 20 patients, including minors down to 12 years old, with a conductive, mixed hearing loss or single-sided deafness will be included. The rationale for including minors is that they are also users of the device, and it is found important to collect data from their experience of using the device as well.

The study is a prospective, multi-center study. It has one visit of 2,5-3 hours for adult subjects ≥18 years old. To minimize the burden and risks of tiredness for the minor subjects from 12-17 years old, the protocol activities can be divided into two visits. The decision will be based on the Investigators discretion.

The majority of the objectives of the study are prospectively collected whereas the BC In-situ (hearing with the Ponto 4 on) and audiometric data from the time of the fitting of Ponto 4, are collected retrospectively from the time of the fitting of Ponto 4.

The overall objectives of the study are to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear(s), in terms of the subject's ability to hear sounds and understand speech when using the device.

The primary endpoint is to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear for patients within intended use.

These will be evaluated through a hearing and a speech test, both assessing the hearing with the Ponto 4(s) both on and off. Additionally, the subject will complete 2 patient reported outcome, report daily usage time of the device and assess satisfaction of connectivity devices.

Minimal risks are expected for subjects participating in the study. Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics. The measurements will require an extra effort and may be found slightly tiring by the subject. To mitigate the risk of tiredness the subject will be given the opportunity to have breaks during the visit.

Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form
2. 12 years old and above
3. Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study
4. Fluent in local language, as judged by the investigator

Exclusion Criteria:

1. Participation in another clinical investigation which might cause interference with study participation.
2. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion

Primary outcomes:
measure: To investigate the improvement in hearing with the Ponto 4 (s) on the implanted ear for patients within intended use.
timeFrame: Visit 1, Day 1
Secondary outcomes:
measure: B. To assess the improvement of hearing with the Ponto 4 on the implanted ear(s).
timeFrame: Visit 1, Day 1
measure: C. To assess the improvement of speech recognition with Ponto 4 on the implanted ear(s).
timeFrame: Visit 1,Day 1
measure: G. To assess the degree to which the Ponto 4 compensates for the BC hearing loss on the implanted ear(s).
timeFrame: After study completion, 6 months
measure: H. To evaluate the above objectives on individual levels
timeFrame: After study completion, 6 months
measure: I. To assess the degree of inner ear hearing loss degradation on the implanted ear(s) (for SSD the stimulated ear).
timeFrame: After study completion, 6 months
measure: J. To assess if a patient's with CHL/MHL hearing loss has degraded to being outside fitting range on the implanted ear(s).
timeFrame: After study completion, 6 months
measure: K. To asses if patients' with CHL/MHL air to bone gap (PTA4) has increased/decreased on the implanted ear(s)
timeFrame: After study completion, 6 moths
Other outcomes:
measure: L. To assess the usage and performance of connectivity device(s)
timeFrame: Visit 1, Day 1
measure: F. To assess the usage time with Ponto 4.
timeFrame: Visit 1, Day 1
measure: E. To assess the quality of life of the Ponto 4
timeFrame: Visit 1, Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)
measure: D. To assess the subjective experience of the Ponto 4
timeFrame: Visit 1,Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week)
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Chris L Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
References: