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Clinical trial study for SOUNDBIT cemented hearing aid in conductive hearing loss

Clinical trial study for SOUNDBIT cemented hearing aid in conductive hearing loss

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022756
Enrollment
Unknown
Registered
2019-04-24
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conductive hearing loss

Interventions

Conductive hearing loss:Bone conduction hearing aid

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The Chinese population (including 18 and 80 years old) who is older than 18 years old and younger than 80 years old, who have been judged by the main investigator to understand and repeat Putonghua, have signed informed consent, and have good compliance and diagnosed as conductive hearing loss. Not less than 3 months. 2. Patients with unilateral conductive deafness, one side of the unilateral conduction deafness has normal hearing, and normal hearing is defined as air conduction (AC) pure tone threshold (PTA) (0.5, 1, 2, 4 kHz) = 25 dB HL. The hearing loss ear is the mean conduction threshold of the humerus (0.5, 1, 2, 4 kHz) = 25 dB HL. 3. Patients with bilateral conductive deafness: Among them, the average ear canal hearing threshold (0.5, 1, 2, 4 kHz) = 25 dB HL. 4. At least two adjacent molars or premolars have no untreated molars. If the patient has dental caries, the teeth should be repaired before fitting the product. 5. The gums are attached to health, the periodontal pocket height is no more than 5mm, and there are no loose teeth.

Exclusion criteria

Exclusion criteria: 1. Other hearing aids are currently being used, such as Baha, CROS and TransEar, etc. The medical causes known to cause deafness are: sensorineural hearing loss and unstable hearing loss. 2. Known to have a life-threatening illness or have contraindications associated with the chosen dental or medical device. 3. Known diseases that may interfere with medical effects, such as inability to breathe through the nasal passages (severe flu, allergies or colds). 4. Those who are allergic to epoxy resin polymers. 5. The tooth is known to have the following abnormal conditions: a. wearing a temporary crown or undergoing dental treatment; b. poor oral hygiene and/or severe tooth decay; c. currently undergoing orthodontics; d. One or more of them have dental caries; e. The device wears moderate to severe periodontitis around the target tooth, f. suspects of having oral or facial damage or any type of swelling; g. mouth, face or neck Any area of ??the Department has severe palpation pain; h. Upper oral teeth have moderate to severe thermal sensitivity; i. Subject is currently undergoing temporomandibular joint treatment, pain, full mouth reconstruction or posterior dental implant In. 6. The speech recognition rate (SRS) is not proportional to the pure tone average hearing threshold. 7. Known psychological or mental problems that may interfere with compliance, understanding, knowledge, and ability to cooperate.

Design outcomes

Primary

MeasureTime frame
Pure tone audiometry;

Countries

CHINA

Contacts

Public ContactFeng Yanmei

Shanghai Sixth People's Hospital

feng.yanmei@126.com+86 18930173985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026