Investigation of an Updated Bone-anchored Sound Processor

Oticon Medical

Status: Completed

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

Treatments: Device: Device B; Device: Device A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05086809

BC109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

AAB

Active Comparator group

Description:

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

Treatment:

Device: Device A

Device: Device B

ABA

Active Comparator group

Description:

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

Treatment:

Device: Device A

Device: Device B