Investigation of an Updated Bone-anchored Sound Processor

NCT ID: NCT05086809

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2021-12-13

Brief Summary

The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.

The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.

Detailed Description

The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor.

The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included.

The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A & Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.

This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.

Conditions

Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Mixed; Hearing Disorders; Deafness; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

AAB

Starts with Device A in first and second trial period and change to Device B in third trial period.

Group Type: ACTIVE_COMPARATOR

Device A

Intervention Type: DEVICE

Participant wear Device A and evaluate the performance of the device.

Device B

Intervention Type: DEVICE

Participant wear Device B and evaluate the performance of the device.

ABA

Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period.

Group Type: ACTIVE_COMPARATOR

Device A

Intervention Type: DEVICE

Participant wear Device A and evaluate the performance of the device.

Device B

Intervention Type: DEVICE

Participant wear Device B and evaluate the performance of the device.

Interventions

Device A

Participant wear Device A and evaluate the performance of the device.

Intervention Type: DEVICE

Device B

Participant wear Device B and evaluate the performance of the device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent Form

2. Adult subjects (18 years or older)

3. Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment

4. Experienced BAHS users with a minimum experience of 3 months.

5. Subjects with:

1. conductive or mixed hearing loss with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 65 dB HL as measured in situ with Ponto 3 SuperPower at Visit 1.

2. OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) as reported in the patient's Noah file.

3. OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS (as per investigator discretion).

6. Fluent in Danish

Exclusion Criteria

Subjects meeting any of the following criteria will not be permitted to participate in the investigation:

1. Known abnormally progressive BC hearing loss as judged by the investigator

2. Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin

3. Participation in another clinical investigation which might cause interference with study participation.

4. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oticon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona El Hichou, MSc

Role: PRINCIPAL_INVESTIGATOR

Oticon Medical c/o Oticon A/S

Locations

Oticon Medical c/o Oticon A/S

Copenhagen, Smørum, Denmark

Countries

Denmark

Other Identifiers

BC109

Identifier Type: -

Identifier Source: org_study_id