## Protocol Section
### Identification Module
**NCT ID:** NCT06418321

**Brief Title:** Early Identification of Age-related Hearing Impairment

**Official Title:** Early Identification of Age-related Hearing Impairment

#### Organization Study ID Info
**ID:** 535/2024
#### Organization
**Class:** OTHER
**Full Name:** Aalto University
### Status Module
#### Completion Date
**Date:** 2026-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Business Finland

**Class:** OTHER

**Name:** Helsinki University Central Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Aalto University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The need for future hearing rehabilitation is enormous. World Health Organization (WHO 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. Currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process.

**Detailed Description:** The investigational device used in the study is part of the Otoscreen hearing screening system that is developed by Aalto University.

The investigational device consists of the following parts:

* Digital otoscope
* User interface control unit.

The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires, digital otoscopy, and audiometry.

The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing.

### Conditions Module

**Conditions:**

- Hearing Loss, Age-Related

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 230

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants are tested with the investigational device and the gold-standard device.

**Intervention Names:**

- Device: Investigational device

- Other: Audiometer

- Device: Otomicroscopy

- Other: REM (Real Ear Measurements)

**Label:** Participant group 1: HUS Helsinki University Hospital

#### Arm Group 2

**Description:** Participants are tested with the investigational device.

**Intervention Names:**

- Device: Investigational device

**Label:** Participant group 2: Aalto University

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participant group 1: HUS Helsinki University Hospital

- Participant group 2: Aalto University

**Description:** The participants' hearing status will be evaluated using the investigational device.

**Name:** Investigational device

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Participant group 1: HUS Helsinki University Hospital

**Description:** Participants' hearing thresholds are tested with an audiogram.

**Name:** Audiometer

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Participant group 1: HUS Helsinki University Hospital

**Description:** The status of the participants' ear canals and tympanic membranes are checked.

**Name:** Otomicroscopy

**Type:** DEVICE

#### Intervention 4

**Arm Group Labels:**

- Participant group 1: HUS Helsinki University Hospital

**Description:** The acoustic properties of the participants' ears will be measured during the interventions.

**Name:** REM (Real Ear Measurements)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators compare scored views to the outer ear canal and tympanic membrane.

**Measure:** Comparison between investigational device and gold-standard device (otomicroscope) findings.

**Time Frame:** From digital otoscopy to the interpretation of pictures (up to six months).

**Description:** The investigators compare pure tone averages.

**Measure:** Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.

**Time Frame:** From hearing tests to the comparison (up to six months).

#### Secondary Outcomes

**Description:** The usability of the investigational device will be assessed using a usability testing protocol. It includes subjective feedback from participants through interviews, questionnaires, and observation of device use. The usability will be assessed using the AttrakDiff method, a standardized questionnaire designed to measure the user's perception of a product's attractiveness, pragmatism, and overall appeal. This method provides insights into both the pragmatic and hedonic aspects of usability. AttrakDiff consists of multiple items scored on a semantic differential scale that consists of seven-step items whose poles are opposite adjectives (e.g. "confusing - clear", "unusual - ordinary", "good - bad"). Each set of adjective items is ordered into a scale of intensity.

Usability testing will be conducted iteratively with the first group of participants (N=20), followed by modifications based on feedback. This iterative process will continue until no negative feedback is received.

**Measure:** Participant group 2: The usability of the investigational device.

**Time Frame:** From study appointment to the analysis of the results (up to six months).

**Description:** If there is a difference between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer, the investigators will look for the REM results if there is an explanation for the difference at the individual level.

**Measure:** Participant group 1: REM measurements.

**Time Frame:** From REM measurements to the analysis of the results (up to six months).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

• Must be able to understand Finnish or Swedish

Exclusion Criteria:

• Clinical diagnosis of hearing loss

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Healthy volunteers

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tanja.tervonen@aalto.fi

**Name:** Tanja Tervonen

**Phone:** +358400240800

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Espoo

**Contacts:**

***Contact 1:***

- **Email:** tanja.tervonen@aalto.fi

- **Name:** Tanja Tervonen

- **Phone:** +358400240800

- **Role:** CONTACT

***Contact 2:***

- **Name:** Wycliffe Raduma, M.Sc.

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Jouni Partanen, Prof.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Poonam Chawda

- **Role:** SUB_INVESTIGATOR

**Country:** Finland

**Facility:** Aalto University

**Status:** RECRUITING

**Zip:** 02150

**Location 2:**

**City:** Helsinki

**Country:** Finland

**Facility:** HUS Head and Neck Center

**Status:** ENROLLING_BY_INVITATION

**Zip:** 00130

#### Overall Officials

**Official 1:**

**Affiliation:** Aalto University

**Name:** Jouni Partanen, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006311

- Term: Hearing Disorders

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006319

- Term: Hearing Loss, Sensorineural

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M24420

- Name: Hearing Loss

- Relevance: HIGH

- As Found: Hearing Impairment

- ID: M6840

- Name: Deafness

- Relevance: HIGH

- As Found: Hearing Impairment

- ID: M14178

- Name: Presbycusis

- Relevance: HIGH

- As Found: Hearing Loss, Age-Related

- ID: M9400

- Name: Hearing Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M9407

- Name: Hearing Loss, Sensorineural

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000034381

- Term: Hearing Loss

- ID: D000003638

- Term: Deafness

- ID: D000011304

- Term: Presbycusis

### Misc Info Module

- Version Holder: 2024-05-31
