NCT05086809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
Last Updated

April 20, 2022

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 27, 2021

Last Update Submit

April 19, 2022

Conditions

Hearing LossHearing Loss, ConductiveHearing Loss, MixedHearing DisordersDeafnessEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System Diseases

Keywords

BAHSPonto

Outcome Measures

Primary Outcomes (1)

  • To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.

    Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).

    4 weeks or 6 weeks

Secondary Outcomes (12)

  • To assess the preference of BAHS sound processor.

    6 weeks

  • To assess the improvement of hearing with Device A.

    Baseline

  • To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL

    Baseline

  • To assess the improvement in speech recognition with Device A in quiet.

    2 weeks

  • To assess performance in speech recognition in noise with Device A and Device B in Omni settings.

    Baseline

  • +7 more secondary outcomes

Other Outcomes (5)

  • To assess the improvement in speech recognition in noise with Device A with OSN ON vs. OSN OFF as a function of hearing loss.

    Baseline and week 4 or week 6

  • To list comments and reactions from the subjects with Device A and Device B.

    Baseline, 2 weeks and 4 weeks

  • To list comments and reactions from the subjects with Device A and Device B.

    2 weeks

  • +2 more other outcomes

Study Arms (2)

AAB

ACTIVE COMPARATOR

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

Device: Device ADevice: Device B

ABA

ACTIVE COMPARATOR

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

Device: Device ADevice: Device B

Interventions

Device ADEVICE

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

AABABA
Device BDEVICE

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

AABABA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form
  • Adult subjects (18 years or older)
  • Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment
  • Experienced BAHS users with a minimum experience of 3 months.
  • Subjects with:
  • 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.
  • 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.
  • 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).
  • Fluent in Danish

You may not qualify if:

  • Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
  • Known abnormally progressive BC hearing loss as judged by the investigator
  • Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin
  • Participation in another clinical investigation which might cause interference with study participation.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oticon Medical c/o Oticon A/S

Copenhagen, Smørum, 2765, Denmark

Location

MeSH Terms

Conditions

Hearing LossHearing Loss, ConductiveHearing Loss, Mixed Conductive-SensorineuralHearing DisordersDeafnessEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System Diseases

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mona El Hichou, MSc

    Oticon Medical c/o Oticon A/S

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants are blinded to the tested conditions in the lab, used for assessment of the primary objective, but the participants are not blinded to the sound processors used during the three trial periods, due to different appearance of the sound processors, making it possible to distinguish between the sound processors.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 21, 2021

Study Start

September 30, 2021

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

April 20, 2022

Record last verified: 2021-10

Locations

DK(1)