Clinical trial NCT05086809: Investigation of an Updated Bone-anchored Sound Processor
Official title: BC109 - Investigation of an Updated Bone-anchored Sound Processor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Mixed
Hearing Disorders
Deafness
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Keywords: BAHS
Ponto
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study includes four laboratory visits and three field trial periods. The first trial period is included to ensure a homogenous baseline. After the first trial period, the study is designed as a two-period, two-sequence crossover trial to compare 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
timeFrame: 4 weeks or 6 weeks
Secondary outcomes:
measure: To assess the preference of BAHS sound processor.
timeFrame: 6 weeks
measure: To assess the improvement of hearing with Device A.
timeFrame: Baseline
measure: To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL
timeFrame: Baseline
measure: To assess the improvement in speech recognition with Device A in quiet.
timeFrame: 2 weeks
measure: To assess performance in speech recognition in noise with Device A and Device B in Omni settings.
timeFrame: Baseline
measure: To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.
timeFrame: 4 weeks or 6 weeks
measure: To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).
timeFrame: 4 weeks or 6 weeks
measure: To assess self-reported performance with Device A and Device B.
timeFrame: 4 weeks or 6 weeks
measure: To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.
timeFrame: 1 week, 4 weeks and 6 weeks
measure: To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.
timeFrame: Baseline and 2 weeks
measure: To assess the difference in BC thresholds as measured in-situ with Device A and Device B.
timeFrame: Baseline
measure: To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.
timeFrame: 1 week, 2 weeks, 4 weeks and 6 weeks
Other outcomes:
measure: To assess the improvement in speech recognition in noise with Device A with OSN ON vs. OSN OFF as a function of hearing loss.
timeFrame: Baseline and week 4 or week 6
measure: To list comments and reactions from the subjects with Device A and Device B.
timeFrame: Baseline, 2 weeks and 4 weeks
measure: To list comments and reactions from the subjects with Device A and Device B.
timeFrame: 2 weeks
measure: To assess usage of device for each field trial period.
timeFrame: 2 weeks, 4 weeks and 6 weeks
measure: To assess usage of device and batteries for each field trial period.
timeFrame: 2 weeks, 4 weeks and 6 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Oticon Medical c/o Oticon A/S
state: Smørum
Study officials:
affiliation: Oticon Medical c/o Oticon A/S
name: Mona El Hichou, MSc
role: PRINCIPAL_INVESTIGATOR
References: