Skip to content

Clinical verification of a sound processors and accessories

Clinical verification of a sound processors and accessories

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17013830
Enrollment
Unknown
Registered
2017-12-11
Start date
2015-04-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Deafness

Interventions

Group over 6 years old:Wearing a sound processor
Group under 6 years old:Wearing a sound processor

Sponsors

EENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. conduction and mixed deafness: 6 years of age and older subjects by pure tone audiometry for ears and bone conduction (BC) of the PTA (PTA, 0.5,1,2, and 3 or 4 kHz) should be less than or equal to 35 dB HL. The PTA difference between bone guided PTA and gas conductance should not be less than 30 dB. For subjects under 6 years old, the ABR test and CAP scale were applied to the right side of the ear. The A8R threshold of bone conduction should be less than or equal to 35 dB HL. The difference between bone conduction A8R threshold and air conduction ABR threshold should be no less than 30 dB.CAP scale should be less than or equal to 3; 2. unilateral sensorineural deafness: 6 years old and above unilateral sensorineural deafness, deaf side should be extremely severe sensorineural hearing loss (0.5. 1.2.3 or 4 kHz test frequency pure tone air conduction threshold value (PTA) should be greater than 90 dB HL), and no obvious effect with traditional hearing aids. The ear in 0.5.1.2.3 or 4 kHz test frequency pure tone air conduction threshold value (PTA) should be less than or equal to 20 dB HL.

Exclusion criteria

Exclusion criteria: 1. combined with serious cardiovascular, brain, liver, kidney, hematopoietic, endocrine system, and other primary diseases; 2. psychosis; 3. women in pregnancy and lactation; 4. participants who are participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Sound field audiometry;Speech recognition domain test;Standard scale test of auditory behavior classification;

Countries

China

Contacts

Public ContactZhang Tianyu

EENT Hospital of Fudan University

Ty.zhang2006@aliyun.com+86 021 64377134-2202

Outcome results

None listed

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