Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear

NCT05628285 | Completed Results

• 1 other identifier: BC114
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.

Conditions

Conductive Hearing Loss; Mixed Hearing Loss

Outcome Measures

Primary Outcomes (1)

• To Assess the Improvement of Hearing With the Sentio1 (PTA4)

  Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4. The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).

  1 month

Secondary Outcomes (6)

• To Assess the Improvement of Hearing With the Sentio1

  1 month

• Subjective Evaluation of Sound Processor Performance.

  1 month

• Subjective Sound Processor Preference

  1 month

• To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss

  1 month

• To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry.

  1 month

Study Arms (1)

Sentio 1 sound processor

EXPERIMENTAL

The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.

Device: Sentio 1

Interventions

Sentio 1 DEVICE

Sound processor

Sentio 1 sound processor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Adult subjects (18 years or older)
• Subjects implanted with an I1 implant
• Fluent in Swedish

You may not qualify if:

• 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.
• Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Habilitation & Health, Hearing organization

Gothenburg, 41663, Sweden

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Oticon Medical AB

studyinfo@oticonmedical.com

0046-31-7486100

Study Officials

• Ann-Charlotte Persson

  Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 28, 2022
• Study Start: November 15, 2022
• Primary Completion: April 25, 2023
• Study Completion: November 15, 2024
• Last Updated: December 3, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)