## Protocol Section
### Identification Module
**NCT ID:** NCT06421766

**Brief Title:** Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures

**Official Title:** Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System (BAHS) Procedures

#### Organization Study ID Info
**ID:** BC122
#### Organization
**Class:** INDUSTRY
**Full Name:** Oticon Medical
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-08

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Oticon Medical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This retrospective study is conducted to gain more knowledge on use and complications of 3mm long implants used in percutaneous (through the skin) bone-anchored hearing system (BAHS) surgeries in adults. Patients included have already been treated and recieved an implant with the wide diameter (Ø: 4.5 mm) design, either of 3- or 4mm length. The main purpose of the study is to investigate implant survival three months after implantation.

**Detailed Description:** BAHS systems are intended for patients with conductive or mixed hearing loss, and for patients with single-sided deafness. In BAHS surgery, an implant - coupled to a skin-penetrating abutment - is implanted in the bone behind the ear and is later loaded with a sound processor. The sound processor transforms sound waves to sound vibrations that are transferred through the skull bone to the inner ear(s)/cochlea. Thus, sound can be transmitted directly to the cochlea and bypass any problems in the ear canal or middle ear. Today, more than 400,000 implantations have been made around the world and the long-term success rate of BAHS surgery is high, with a low rate of major complications.

Over the years, both implant design and surgical techniques have developed, with improved patient outcomes as a result. Wider diameter implants, 4.5mm in diameter, increased the implant stability and have become standard. The implants exist in two different lengths, 3- and 4mm, to accomodate for different bone thickness. The shorter implant has primarily been used for (young) children and for adults with thinner bone. The aim of this restrospective study is to investigate the outcomes after implantation of a 3mm implant in an adult population.

### Conditions Module

**Conditions:**

- Hearing Loss

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients recieving a 3mm long implant

**Intervention Names:**

- Device: BAHS

**Label:** 3mm implant

#### Arm Group 2

**Description:** Patients recieving a 4mm long implant

**Intervention Names:**

- Device: BAHS

**Label:** 4mm implant

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 3mm implant

- 4mm implant

**Description:** Implantation of a percutaneous bone-anchored hearing system

**Name:** BAHS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Implant in place in skull bone at 3 months (Yes/No).

**Measure:** Implant survival

**Time Frame:** 3 months after implant surgery

#### Secondary Outcomes

**Description:** Implant in place in skull bone at end of observation (Yes/No).

**Measure:** Implant survival

**Time Frame:** Through study completion, with minimum 3 months

**Description:** Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table.

**Measure:** Number and type of intraoperative events

**Time Frame:** During surgery

**Description:** Assessment of postoperative events during the initial postoperative period (0-3 months) by the investigator. Will be presented in a frequency table.

**Measure:** Number and type of postoperative events

**Time Frame:** Up to 3 months

**Description:** Time from surgery to sound processor loading

**Measure:** Time to sound processor loading

**Time Frame:** Up to 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patient (≥19 years) receiving percutaneous BAHS treatment using an implant with the wide diameter (Ø: 4.5 mm) design.

Exclusion Criteria:

* Patient undergoing re-implantation due to previous failure of osseointegration or other spontaneous implant loss.
* Patient undergoing conversions from passive transcutaneous devices (i.e. BAHA Attract) to active percutaneous devices (using an abutment), using the same implant for attachment.

**Minimum Age:** 19 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients that have already obtained surgical intervention with a percutaneous bone anchored hearing system.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ssve@oticonmedical.com

**Name:** Sara Svensson, PhD

**Phone:** +46735042041

**Role:** CONTACT

**Contact 2:**

**Email:** nitc@oticonmedical.com

**Name:** Nicole Amichetti, PhD

**Phone:** +1 609-366-0424

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Birmingham

**Contacts:**

***Contact 1:***

- **Name:** Dennis G Pappas, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** Alabama Ear Specialists

**State:** Alabama

**Status:** RECRUITING

**Zip:** 25233

#### Overall Officials

**Official 1:**

**Affiliation:** Alabama Ear Specialists

**Name:** Dennis G Pappas, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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

### 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 Loss

- ID: M6840

- Name: Deafness

- Relevance: LOW

- As Found: Unknown

- 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

### Condition Browse Module - Meshes

- ID: D000034381

- Term: Hearing Loss

### Misc Info Module

- Version Holder: 2024-05-31
